FDA Adverse Event
Malfunction
Summary report: N
ATLAS OBS 10/25/04
MDR report key: 2924515
·
Received January 22, 2013
Report
- Report Number
- 0001831750-2013-00217
- Event Type
- Malfunction
- Date Received
- January 22, 2013
- Date of Event
- January 2, 2013
- Report Date
- January 2, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION CONCLUDED THAT THE RIGHT SIDE RAIL HAD ACCESSIBLE SHARP EDGES AT THE BROKEN WELD OF THE FOOT RIGHT SIDE RAIL LATCH.
Additional Manufacturer Narrative · 1
RESULT: BROKEN WELD AT FOOT RIGHTT SIDE RAIL LATCH.
Description of Event or Problem · 1
THE INVESTIGATION CONCLUDED THAT THE RIGHT SIDE RAIL HAD ACCESSIBLE SHARP EDGES AT THE BROKEN WELD OF THE FOOT RIGHT SIDE RAIL LATCH.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE RIGHT SIDE RAIL COULD NOT LATCH IN THE RAISED POSITION DUE TO A BROKEN WELD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 28947 | ATLAS OBS 10/25/04 | STRETCHER, WHEELED | FPO | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |