FDA Adverse Event
Malfunction
Summary report: N
CAPITAL SPR PLUS III PUMP
MDR report key: 2760317
·
Received September 20, 2012
Report
- Report Number
- 1313850-2012-00293
- Event Type
- Malfunction
- Date Received
- September 20, 2012
- Date of Event
- August 22, 2012
- Report Date
- August 22, 2012
- Manufacturer
- STRYKER CORP DBA GAYMAR
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE POWER CORD HAS EXPOSED WIRES. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAPITAL SPR PLUS III PUMP | PUMP | FRN | STRYKER CORP DBA GAYMAR | CL360 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |