FDA Adverse Event
Malfunction
Summary report: N
RENAISSANCE 26 OBS 10/25/04
MDR report key: 3193026
·
Received June 27, 2013
Report
- Report Number
- 0001831750-2013-05852
- Event Type
- Malfunction
- Date Received
- June 27, 2013
- Date of Event
- May 20, 2013
- Report Date
- May 31, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE SIDE RAIL COULD BECOME UNLATCHD DURING USE DUE TO MISSING COMPRESSION SPRING. 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 |
|---|---|---|---|---|---|---|---|
| 292672 | RENAISSANCE 26 OBS 10/25/04 | STRETCHER, WHEELED | FPO | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |