MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. SYSTEMONE ASV4; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number 560P

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Dyspnea (1816); Unspecified Infection (1930); Myocardial Infarction (1969); Sepsis (2067); Vomiting (2144); Confusion/ Disorientation (2553); Heart Failure/Congestive Heart Failure (4446); Liver Failure (4492); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/27/2020

Event Type  Death  

Event Description

(b)(6) randomly started to vomit and feel ill one afternoon at work.Twenty four hours later he was very confused, could not answer simple questions.He was taken to er, quickly admitted, tests showed sepsis.A few hours later he needed to be intubated as he was having severe breathing problems.During intubation he went into cardiac arrest, he survived.Tests showed his infection was in his aorta valve, and severely damaged.Tests showed he had numerous strokes, heart failure, liver failure, kidney failure, 10 days after first symptom he was declared brain dead and the decision was made to remove him from the ventilator, he died a few minutes later.Fda safety report id# (b)(4).

• Brand Name: SYSTEMONE ASV4
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12512827
• MDR Text Key: 272888792
• Report Number: MW5104117
• Device Sequence Number: 1
• Product Code: MNS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 560P
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/21/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 57 YR
• Patient Weight: 122