FDA Adverse Event
Malfunction
Summary report: N
WIRELESS BATTERY MODULE G
MDR report key: 3003426
·
Received February 13, 2013
Report
- Report Number
- 1314492-2013-00098
- Event Type
- Malfunction
- Date Received
- February 13, 2013
- Report Date
- January 16, 2013
- Manufacturer
- BAXTER HEALTHCARE CORP.
- Product Code
- FRN
- PMA / PMN Number
- K042121
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). BAXTER EVALUATED THE DEVICE IN QUESTION AND IT WAS OBSERVED THAT THE PUMP LOST POWER WHEN THE DEVICE'S MOTOR ENGAGED. THIS WAS FOUND TO BE CAUSED BY A FAILED BATTERY CELL OF THE WIRELESS BATTERY MODULE. AT THIS TIME, THE DATE OF EVENT IS UNKNOWN.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PUMP WOULD TURN OFF BY ITSELF WHILE ON DC POWER AFTER THE RUN/STOP KEY WAS PRESSED. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 63734 | WIRELESS BATTERY MODULE G | WIRELESS BATTERY MODULE | FRN | BAXTER HEALTHCARE CORP. | 35083 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | SPECTRUM PUMP, S/N: (B)(4) |