FDA Adverse Event
Malfunction
Summary report: N
GYNNIE OB-GYN STRETCHER
MDR report key: 2901463
·
Received January 8, 2013
Report
- Report Number
- 0001831750-2013-00006
- Event Type
- Malfunction
- Date Received
- January 8, 2013
- Date of Event
- December 14, 2012
- Report Date
- December 14, 2012
- Manufacturer
- STRYKER
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURER'S INVESTIGATION IS ONGOING. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT MAY BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE CUSTOMER DISASSEMBLED THE BASE TO REPAIR THE BRAKES. THEY WERE NOT ABLE TO COMPLETE REPAIRS AND THE STRYKER TECHNICIAN WAS CALLED TO COMPLETE THE REPAIRS. NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 9387 | GYNNIE OB-GYN STRETCHER | DEVICE, TRANSFER, PATIENT, MANUAL | FPO | STRYKER | 1061 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |