scholarly journals A review of hospital based ventilator malfunctions reported to the FDA in 2021

2021 ◽  
Vol 2 (4) ◽  
pp. 142-146
Author(s):  
Stephen Tunnell

Ventilator care is synonymous with Intensive care. These devices are electromechanical and as such can fail. Most failures are without patient incident, injury, and harm. The FDA requires manufacturers who learn of malfunction, injury or death while operating their product to report to the agency via the Manufacturer and User Facility Device Experience database. I reviewed 500 recent events reported to the FDA and found an increasing trend from 2020 to 2021 in hospital ventilator malfunction reports. Examination of these reports is critical to assuring quality ventilator care. The author concluded that intensive training on the device characteristics and feature and a more rigorous examination of ventilator performance between patients may assist in reducing device malfunctions. Keywords: Mechanical ventilation, Ventilator malfunction, FDA

2021 ◽  
Vol 8 ◽  
pp. 2333794X2199153
Author(s):  
Ameer Al-Hadidi ◽  
Morta Lapkus ◽  
Patrick Karabon ◽  
Begum Akay ◽  
Paras Khandhar

Post-extubation respiratory failure requiring reintubation in a Pediatric Intensive Care Unit (PICU) results in significant morbidity. Data in the pediatric population comparing various therapeutic respiratory modalities for avoiding reintubation is lacking. Our objective was to compare therapeutic respiratory modalities following extubation from mechanical ventilation. About 491 children admitted to a single-center PICU requiring mechanical ventilation from January 2010 through December 2017 were retrospectively reviewed. Therapeutic respiratory support assisted in avoiding reintubation in the majority of patients initially extubated to room air or nasal cannula with high-flow nasal cannula (80%) or noninvasive positive pressure ventilation (100%). Patients requiring therapeutic respiratory support had longer PICU LOS (10.92 vs 6.91 days, P-value = .0357) and hospital LOS (16.43 vs 10.20 days, P-value = .0250). Therapeutic respiratory support following extubation can assist in avoiding reintubation. Those who required therapeutic respiratory support experienced a significantly longer PICU and hospital LOS. Further prospective clinical trials are warranted.


2004 ◽  
Vol 14 (8) ◽  
pp. 1036-1041 ◽  
Author(s):  
Thomas S. Helling ◽  
Thomas L. Willoughby ◽  
Daniel M. Maxfield ◽  
Patricia Ryan

2019 ◽  
Vol 9 (1) ◽  
Author(s):  
Youenn Jouan ◽  
Leslie Grammatico-Guillon ◽  
Noémie Teixera ◽  
Claire Hassen-Khodja ◽  
Christophe Gaborit ◽  
...  

Abstract Background The post intensive care syndrome (PICS) gathers various disabilities, associated with a substantial healthcare use. However, patients’ comorbidities and active medical conditions prior to intensive care unit (ICU) admission may partly drive healthcare use after ICU discharge. To better understand retative contribution of critical illness and PICS—compared to pre-existing comorbidities—as potential determinant of post-critical illness healthcare use, we conducted a population-based evaluation of patients’ healthcare use trajectories. Results Using discharge databases in a 2.5-million-people region in France, we retrieved, over 3 years, all adult patients admitted in ICU for septic shock or acute respiratory distress syndrome (ARDS), intubated at least 5 days and discharged alive from hospital: 882 patients were included. Median duration of mechanical ventilation was 11 days (interquartile ranges [IQR] 8;20), mean SAPS2 was 49, and median hospital length of stay was 42 days (IQR 29;64). Healthcare use (days spent in healthcare facilities) was analyzed 2 years before and 2 years after ICU admission. Prior to ICU admission, we observed, at the scale of the whole study population, a progressive increase in healthcare use. Healthcare trajectories were then explored at individual level, and patients were assembled according to their individual pre-ICU healthcare use trajectory by clusterization with the K-Means method. Interestingly, this revealed diverse trajectories, identifying patients with elevated and increasing healthcare use (n = 126), and two main groups with low (n = 476) or no (n = 251) pre-ICU healthcare use. In ICU, however, SAPS2, duration of mechanical ventilation and length of stay were not different across the groups. Analysis of post-ICU healthcare trajectories for each group revealed that patients with low or no pre-ICU healthcare (which represented 83% of the population) switched to a persistent and elevated healthcare use during the 2 years post-ICU. Conclusion For 83% of ARDS/septic shock survivors, critical illness appears to have a pivotal role in healthcare trajectories, with a switch from a low and stable healthcare use prior to ICU to a sustained higher healthcare recourse 2 years after ICU discharge. This underpins the hypothesis of long-term critical illness and PICS-related quantifiable consequences in healthcare use, measurable at a population level.


2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S257-S258
Author(s):  
Raul Davaro ◽  
alwyn rapose

Abstract Background The ongoing pandemic of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections has led to 105690 cases and 7647 deaths in Massachusetts as of June 16. Methods The study was conducted at Saint Vincent Hospital, an academic health medical center in Worcester, Massachusetts. The institutional review board approved this case series as minimal-risk research using data collected for routine clinical practice and waived the requirement for informed consent. All consecutive patients who were sufficiently medically ill to require hospital admission with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection by positive result on polymerase chain reaction testing of a nasopharyngeal sample were included. Results A total of 109 consecutive patients with COVID 19 were admitted between March 15 and May 31. Sixty one percent were men, the mean age of the cohort was 67. Forty one patients (37%) were transferred from nursing homes. Twenty seven patients died (24%) and the majority of the dead patients were men (62%). Fifty one patients (46%) required admission to the medical intensive care unit and 34 necessitated mechanical ventilation, twenty two patients on mechanical ventilation died (63%). The most common co-morbidities were essential hypertension (65%), obesity (60%), diabetes (33%), chronic kidney disease (22%), morbid obesity (11%), congestive heart failure (16%) and COPD (14%). Five patients required hemodialysis. Fifty five patients received hydroxychloroquine, 24 received tocilizumab, 20 received convalescent plasma and 16 received remdesivir. COVID 19 appeared in China in late 2019 and was declared a pandemic by the World Health Organization on March 11, 2020. Our study showed a high mortality in patients requiring mechanical ventilation (43%) as opposed to those who did not (5.7%). Hypertension, diabetes and obesity were highly prevalent in this aging population. Our cohort was too small to explore the impact of treatment with remdesivir, tocilizumab or convalescent plasma. Conclusion In this cohort obesity, diabetes and essential hypertension are risk factors associated with high mortality. Patients admitted to the intensive care unit who need mechanical ventilation have a mortality approaching 50 %. Disclosures All Authors: No reported disclosures


Author(s):  
Nathan J Smischney ◽  
Venu M Velagapudi ◽  
James A Onigkeit ◽  
Brian W Pickering ◽  
Vitaly Herasevich ◽  
...  

2021 ◽  
Vol 32 (5) ◽  
pp. 435-443
Author(s):  
Maria Elena Ceballos ◽  
Patricio Ross ◽  
Martin Lasso ◽  
Isabel Dominguez ◽  
Marcela Puente ◽  
...  

In this prospective, multicentric, observational study, we describe the clinical characteristics and outcomes of people living with HIV (PLHIV) requiring hospitalization due to COVID-19 in Chile and compare them with Chilean general population admitted with SARS-CoV-2. Consecutive PLHIV admitted with COVID-19 in 23 hospitals, between 16 April and 23 June 2020, were included. Data of a temporally matched-hospitalized general population were used to compare demography, comorbidities, COVID-19 symptoms, and major outcomes. In total, 36 PLHIV subjects were enrolled; 92% were male and mean age was 44 years. Most patients (83%) were on antiretroviral therapy; mean CD4 count was 557 cells/mm3. Suppressed HIV viremia was found in 68% and 56% had, at least, one comorbidity. Severe COVID-19 occurred in 44.4%, intensive care was required in 22.2%, and five patients died (13.9%). No differences were seen between recovered and deceased patients in CD4 count, HIV viral load, or time since HIV diagnosis. Hypertension and cardiovascular disease were associated with a higher risk of death ( p = 0.02 and 0.006, respectively). Compared with general population, the HIV cohort had significantly more men (OR 0.15; IC 95% 0.07–0.31) and younger age (OR 8.68; IC 95% 2.66–28.31). In PLHIV, we found more intensive care unit admission (OR 2.31; IC 95% 1.05–5.07) but no differences in the need for mechanical ventilation or death. In this cohort of PLHIV hospitalized with COVID-19, hypertension and cardiovascular comorbidities, but not current HIV viro-immunologic status, were the most important risk factors for mortality. No differences were found between PLHIV and general population in the need for mechanical ventilation and death.


Geriatrics ◽  
2021 ◽  
Vol 6 (2) ◽  
pp. 36
Author(s):  
David G Smithard ◽  
Nadir Abdelhameed ◽  
Thwe Han ◽  
Angelo Pieris

Discussion regarding cardiopulmonary resuscitation and admission to an intensive care unit is frequently fraught in the context of older age. It is complicated by the fact that the presence of multiple comorbidities and frailty adversely impact on prognosis. Cardiopulmonary resuscitation and mechanical ventilation are not appropriate for all. Who decides and how? This paper discusses the issues, biases, and potential harms involved in decision-making. The basis of decision making requires fairness in the distribution of resources/healthcare (distributive justice), yet much of the printed guidance has taken a utilitarian approach (getting the most from the resource provided). The challenge is to provide a balance between justice for the individual and population justice.


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