FDA Adverse Event
Malfunction
Summary report: N
TEMP PUMP PRO
MDR report key: 2033368
·
Received March 22, 2011
Report
- Report Number
- 1313850-2011-00013
- Event Type
- Malfunction
- Date Received
- March 22, 2011
- Date of Event
- January 24, 2011
- Report Date
- January 24, 2011
- Manufacturer
- GAYMAR INDUSTRIES, INC.
- Product Code
- ILO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THERE WAS FLUID INGRESS ON THE CONTROL BOARD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TEMP PUMP PRO | PUMP | ILO | GAYMAR INDUSTRIES, INC. | TP700 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |