FDA Adverse Event
Malfunction
Summary report: N
RENAISSANCE 26 P-WASS 10/04
MDR report key: 3170084
·
Received June 14, 2013
Report
- Report Number
- 0001831750-2013-05410
- Event Type
- Malfunction
- Date Received
- June 14, 2013
- Date of Event
- May 1, 2013
- Report Date
- May 20, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE SIDE RAIL COULD NOT BE LATCHED IN PLACE DUE TO DAMAGED LATCHING BRACKET WELD. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 271669 | RENAISSANCE 26 P-WASS 10/04 | STRETCHER, WHEELED | FPO | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |