FDA Adverse Event Malfunction Summary report: N

COMPASS HEALTH BRANDS

MDR report key: 20256380 · Received September 19, 2024

Report

Report Number
3012316249-2024-00020
Event Type
Malfunction
Date Received
September 19, 2024
Date of Event
August 13, 2024
Report Date
September 19, 2024
Manufacturer
JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO., LTD
Product Code
CAW
UDI-DI
00092237623152
Product Problem
Yes
Report Source
Distributor report
Reporter Location
GA, US
Reporter Occupation
003

Narratives

Description of Event or Problem · 0

WE HAD A CONCENTRATOR THAT CAUGHT ON FIRE IN A PATIENT'S HOME ON (B)(6) 2024. THE PATIENT HAD NO INJURIES AND DID NOT REQUIRE MEDICAL ATTENTION. THE PATIENT WAS IN A DIFFERENT ROOM FROM THE CONCENTRATOR. THE CONCENTRATOR WAS LOCATED IN THEIR BATHROOM, BECAUSE THEY DID NOT LIKE THE NOISE FROM THE CONCENTRATOR. THE DAUGHTER USED A FIRE EXTINGUISHER TO PUT THE OUT THE FIRE FROM THE CONCENTRATOR. THE FIRE DEPARTMENT WAS CALLED OUT BY THE DAUGHTER AFTER THE FIRE WAS EXTINGUISHED. PER THE DAUGHTER, THE CONCENTRATOR WAS TAKEN BY THE INSURANCE COMPANY. SHE WILL ASK IF SHE CAN GET IT BACK AND LET ME KNOW. THE FAMILY CALLED ME BACK AND THE FIRE INVESTIGATOR HAS THE CONCENTRATOR. THEY JUST SPOKE WITH HIM, AND THEY WILL NOT BE RELEASING THE CONCENTRATOR TO ANYONE. HE SAID THEY WOULD BE HAPPY TO DO A DUAL INVESTIGATION WITH THE MANUFACTURER/COMPANY. THIS EVENT IS NOT CONSIDERED A MANDATORY REPORTABLE EVENT AS THERE WAS NO REPORT OF DEATH OR SERIOUS INJURY. THE PRESENCE OR ABSENCE OF A MALFUNCTION CANNOT BE DETERMINED WITH THE INFORMATION CURRENTLY AVAILABLE. HOWEVER, THE MANUFACTURER HAS DECIDED TO MAKE THE FDA AWARE OF THE INCIDENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1632798 COMPASS HEALTH BRANDS TRUAIRE 5 O2 CONCENTRATOR CAW JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO., LTD O2C5L 00092237623152

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown Other