FDA Adverse Event
Malfunction
Summary report: N
AERX
MDR report key: 20962720
·
Received December 18, 2024
Report
- Report Number
- 3009096682-2024-00110
- Event Type
- Malfunction
- Date Received
- December 18, 2024
- Date of Event
- November 19, 2024
- Report Date
- December 18, 2024
- Manufacturer
- MME WILLOW LAKE
- Product Code
- CAW
- PMA / PMN Number
- K200496
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 0
REACT HEALTH RECEIVED A COMPLAINT FROM A DURABLE MEDICAL EQUIPMENT PROVIDER THAT A DEVICE HAD A BURNING SMELL DURING TESTING. THERE WAS NO HARM OR INJURY REPORTED. THE UNIT HAS BEEN RETURNED TO THE MANUFACTURER. THE DEVICE WAS EVALUATED BY THE MANUFACTURER. THE DEVICE WOULD NOT POWER UP FOR PERFORMANCE TESTING. THERE WAS NO EVIDENCE OF BURNING OR SMOKE DAMAGE OBSERVED. IT WAS DETERMINED THE MAIN PCBA WAS FAULTY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 292260 | AERX | GENERATOR, OXYGEN, PORTABLE | CAW | MME WILLOW LAKE | AX1000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |