MAUDE Adverse Event Report: RESPIRONICS INC. EVERFLO; GENERATOR, OXYGEN, PORTABLE

Model Number O25LCONCENTRATOR

Device Problems Fire (1245); Smoking (1585); Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Date 03/15/2021

Event Type  malfunction  

Event Description

Family contact called stating that the 5 l concentrator was beeping.I advised i would create a service.As i was trying to locate the patients information, he stated that the concentrator was smoking and it was on fire.He managed to place the concentrator outside the home.He requested to speak to a supervisor.I attempted to contact my supervisor without success.I explained that i would keep trying to get a supervisor for him but asked if i could call him back.He stated that he prefer that someone follow up with him in the morning but he wants the new concentrator tonight.Fa21.2001.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: EVERFLO
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS INC.
• MDR Report Key: 17526580
• MDR Text Key: 321038866
• Report Number: MW5133519
• 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: 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: O25LCONCENTRATOR
• Patient Sequence Number: 1