FDA Adverse Event
Malfunction
Summary report: N
GYNNIE OB-GYN STRETCHER
MDR report key: 3081071
·
Received April 26, 2013
Report
- Report Number
- 0001831750-2013-03793
- Event Type
- Malfunction
- Date Received
- April 26, 2013
- Date of Event
- April 2, 2013
- Report Date
- April 2, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE BRAKES WOULD NOT HOLD DUE TO THE BRAKE ADJUSTER BEING BROKEN AND ALSO THE BRAKE RING WAS DAMAGED. 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 |
|---|---|---|---|---|---|---|---|
| 180933 | GYNNIE OB-GYN STRETCHER | STRETCHER, WHEELED | FPO | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |