MAUDE Adverse Event Report: PHILIPS RESPIRONICS REMSTAR AUTO A-FLEX

Model Number PHILIPS RESPIRONICS REMSTAR AUTO

Device Problems Device Alarm System (1012); Loss of Power (1475); No Pressure (2994)

Patient Problem Hypoxia (1918)

Event Type  Injury  

Event Description

Philips respironics remstar a-flex shuts off in use without warning, beeps or alerts while consumer is already asleep.Causing blocked breathing as no air pressure is being exerted.Also non sufficient or mechanical back up to allow consumer to breathe when machine is malfunctioning.Basically, consumer wakes up usually due to hypoxia or inability to breathe.Which is what the cpap is designed to correct.This malfunction has happened several times and always after the machine begins to provide air pressure and consumer falls asleep.

• Brand Name: RESPIRONICS REMSTAR AUTO A-FLEX
• Type of Device: RESPIRONICS REMSTAR AUTO A-FLEX
• Manufacturer (Section D): PHILIPS
• MDR Report Key: 4856256
• MDR Text Key: 21326668
• Report Number: MW5043128
• Device Sequence Number: 1
• Product Code: BZD
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/14/2015

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: PHILIPS RESPIRONICS REMSTAR AUTO
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/14/2015
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 38 YR
• Patient Weight: 161