FDA Adverse Event
Malfunction
Summary report: N
ST104 TRANSPORT OBS 3/07
MDR report key: 3061853
·
Received April 16, 2013
Report
- Report Number
- 0001831750-2013-03372
- Event Type
- Malfunction
- Date Received
- April 16, 2013
- Date of Event
- March 20, 2013
- Report Date
- March 20, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE BRAKES WERE NOT HOLDING DUE TO WORN HEAD AND FOOT END BRAKE RINGS. 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 |
|---|---|---|---|---|---|---|---|
| 162747 | ST104 TRANSPORT OBS 3/07 | STRETCHER, WHEELED | FPO | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |