FDA Adverse Event
Other
Summary report: N
FREESTYLE BATTERY PACK (ACCESSORY)
MDR report key: 1993359
·
Received February 7, 2011
Report
- Report Number
- 1319044-2011-00004
- Event Type
- Other
- Date Received
- February 7, 2011
- Date of Event
- January 10, 2011
- Report Date
- February 5, 2011
- Manufacturer
- AIRSEP CORP
- Product Code
- CAW
- PMA / PMN Number
- K020324
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE EVALUATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
THE BATTERY BELT FELL OFF THE BED AND HIT THE FLOOR AND BEGAN TO POP AND A FLAME OCCURRED. THE BATTERY WAS PLACED IN SINK TO PUT OUT FLAMES. NO INJURIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FREESTYLE BATTERY PACK (ACCESSORY) | OXYGEN CONCENTRATOR | CAW | AIRSEP CORP | BT017-1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention |