FDA Adverse Event
Malfunction
Summary report: N
POWER PRO AMBULANCE COT
MDR report key: 3211695
·
Received July 8, 2013
Report
- Report Number
- 0001831750-2013-06151
- Event Type
- Malfunction
- Date Received
- July 8, 2013
- Date of Event
- June 10, 2013
- Report Date
- June 10, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE HEAD SECTION WAS NOT FUNCTIONING CORRECTLY DUE TO THE MOUNTING BOLTS BEING PULLED THROUGH THE SLIDE BEARINGS. 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 |
|---|---|---|---|---|---|---|---|
| 312076 | POWER PRO AMBULANCE COT | STRETCHER, WHEELED | FPO | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |