FDA Adverse Event
Malfunction
Summary report: N
ADVANTAGE SERIES 29 OBS 10/04
MDR report key: 3112361
·
Received May 14, 2013
Report
- Report Number
- 0001831750-2013-04373
- Event Type
- Malfunction
- Date Received
- May 14, 2013
- Date of Event
- April 17, 2013
- Report Date
- April 17, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE TOP RAIL WAS BROKEN RESULTING IN LESS THAN HALF OF THE SIDE RAIL ABLE TO REMAIN LATCHED. 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 |
|---|---|---|---|---|---|---|---|
| 213218 | ADVANTAGE SERIES 29 OBS 10/04 | STRETCHER, WHEELED | FPO | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |