FDA Adverse Event
Malfunction
Summary report: N
ADVANTAGE SERIES 29 OBS 10/04
MDR report key: 3160149
·
Received June 10, 2013
Report
- Report Number
- 0001831750-2013-05256
- Event Type
- Malfunction
- Date Received
- June 10, 2013
- Date of Event
- May 14, 2013
- Report Date
- May 14, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE LEFT SIDE RAIL COULD BECOME UNLATCHED DURING USE DUE TO A 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 |
|---|---|---|---|---|---|---|---|
| 260261 | ADVANTAGE SERIES 29 OBS 10/04 | STRETCHER, WHEELED | FPO | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |