MAUDE Adverse Event Report: RESMED ELITE S8 CPAP MACHINE

Device Problems Fire (1245); Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/24/2016

Event Type  Injury  

Event Description

My resmed s8 cpap machine malfunctioned and flames appeared at the back of the machine.

• Brand Name: CPAP MACHINE
• Type of Device: CPAP MACHINE
• Manufacturer (Section D): RESMED ELITE S8
• MDR Report Key: 5910377
• MDR Text Key: 53380193
• Report Number: MW5064397
• Device Sequence Number: 1
• Product Code: BZD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: RX MEDS: NONE.
• Patient Outcome(s): Life Threatening
• Patient Age: 50 YR