FDA Adverse Event
Malfunction
Summary report: N
TEMP PUMP CLASSIC
MDR report key: 2090568
·
Received April 19, 2011
Report
- Report Number
- 1313850-2011-00083
- Event Type
- Malfunction
- Date Received
- April 19, 2011
- Date of Event
- February 28, 2011
- Report Date
- March 23, 2011
- Manufacturer
- STRYKER CORP DBA GAYMAR
- Product Code
- ILO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS EVIDENCE OF FLUID INGRESS TO THE PCB BOARD. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TEMP PUMP CLASSIC | PUMP | ILO | STRYKER CORP DBA GAYMAR | TP650 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |