PHILIPS CPAP SYSTEM ONE REMSTAR AUTO A-FLEX MODEL 560 (SEE PICTURE) REMSTAR AUTO 560

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-10 for PHILIPS CPAP SYSTEM ONE REMSTAR AUTO A-FLEX MODEL 560 (SEE PICTURE) REMSTAR AUTO 560 manufactured by Philips / Respironics, Inc..

Event Text Entries

[178377994] Philips respironics system one cpap/apap model 560 melted down and began to catch fire. In the middle of the night in mid december the unit began smoking. I think this may have happened over two separate nights as the first time i woke with an odd taste in my mouth and eye irritation which i could not attribute to anything. The second time it happened i awoke again with the taste in my mouth but also aware of smoke coming out the top of the cpap unit. The next day i opened the unit up and took the attached pictures. Contact with philips has provided no fruitful result except that they asked for me to send them the unit, but no replacement offered. I found this behavior rather reprehensible, akin to boeing's 747 max behavior. It appears the wire harness assembly contact joints onto the controlled board are / were adequate of that the crimping of the contacts within the plug were done incorrectly. Regardless, if other units have similar issues this could be a real fire hazard which by its nature happens bedside while the unaware occupant is only a few feet away and asleep. A double danger in the making. I've attached pictures and s/n info from the unit. Someone should be asking philips if they or any of their repair service centers have had similar harness failures. If they have, then a recall on all heated system one wire harnesses should be considered. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5092880
• MDR Report Key: 9687125
• Date Received: 2020-02-10
• Date of Report: 2020-02-07
• Date of Event: 2019-12-19
• Date Added to Maude: 2020-02-10
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PHILIPS CPAP SYSTEM ONE REMSTAR AUTO A-FLEX MODEL 560 (SEE PICTURE)
• Generic Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Product Code: BZD
• Date Received: 2020-02-10
• Model Number: REMSTAR AUTO 560
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: PHILIPS / RESPIRONICS, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Life Threatening	2020-02-10