MAUDE Adverse Event Report: PHILIPS-RESPIRONICS INC. OXYGEN CONCENTRATOR; GENERATOR, OXYGEN, PORTABLE

Model Number EVERFLO

Device Problem Fire (1245)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 02/05/2013

Event Type  Death  

Event Description

Patient was letting her husband use her equipment (s/n (b)(6)) because he was complaining about shortness of breath.When he put it on, he told his wife that the oxygen coming through the cannula felt warmer than usual.It was then that the unit caught on fire and burnt (b)(6) on his face, arms, lap and chest.(b)(6) had to pour glasses of water on him to put out the flames.(b)(6) is now in the hospital with serious burns and was airlifted to the burn center to get more intense treatment.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: OXYGEN CONCENTRATOR
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): PHILIPS-RESPIRONICS INC.
• MDR Report Key: 17516411
• MDR Text Key: 321038034
• Report Number: MW5123360
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/06/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: EVERFLO
• Patient Sequence Number: 1