MAUDE Adverse Event Report: PHILIPS HEALTHCARE / RESPIRONICS, INC. BIPAP; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE

Model Number V60

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

Patient Problems Apnea (1720); Cardiac Arrest (1762); Chest Pain (1776); Dyspnea (1816); Loss of consciousness (2418)

Event Date 05/20/2022

Event Description

A (b)(6) presented to the ed for respiratory distress with sudden onset of shortness of breath.Had chest tightness earlier in the day.During the ed visit, bipap was started.It is hypothesized that the patient a medical event, slumped down, and the tubing was disconnected from the patient's bipap mask to the bipap machine.After the tubing disconnection, the bipap alarm went off for 6 minutes, was set at 2 (10 high scale), not heard by staff.Volume escalation was turned off.The patient's heart rate dropped and the physician was alerted to this.Pt found unresponsive, pulseless, apneic.Code blue called.It is not clear if the bipap disconnection led to the patient's respiratory/cardiac arrest or if the patient had a medical event prior to the mask disconnection.Fda safety report id# (b)(4).

• Brand Name: BIPAP
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): PHILIPS HEALTHCARE / RESPIRONICS, INC.
• MDR Report Key: 14593584
• MDR Text Key: 293461292
• Report Number: MW5110089
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: V60
• Device Catalogue Number: 85008
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/02/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CPAP (HOME USE)
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White