FDA Adverse Event
Malfunction
Summary report: N
MX-PRO AMBULANCE COT OBS 10/01
MDR report key: 3130169
·
Received May 24, 2013
Report
- Report Number
- 0001831750-2013-04738
- Event Type
- Malfunction
- Date Received
- May 24, 2013
- Date of Event
- April 5, 2013
- Report Date
- April 5, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE TORSION SPRINGS ARE BROKEN WHICH CAN AFFECT FUNCTIONALITY OF THE SAFETY BAR. 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 |
|---|---|---|---|---|---|---|---|
| 231943 | MX-PRO AMBULANCE COT OBS 10/01 | STRETCHER, WHEELED | FPO | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |