FDA Adverse Event
Malfunction
Summary report: N
PRIME BIG WHEEL STRETCHER, 30"
MDR report key: 2960359
·
Received January 11, 2013
Report
- Report Number
- 1831750-2013-90393
- Event Type
- Malfunction
- Date Received
- January 11, 2013
- Date of Event
- December 17, 2012
- Report Date
- December 17, 2012
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE REASON FOR THE SERIALIZATION STARTING WITH 90XXX IS TO PROVIDE CLARIFICATION FOLLOWING A CHANGE IN STRYKER'S ELECTRONIC COMPLAINT SYSTEMS.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE HEAD END JACK COULD NOT BE RAISED; HOWEVER, STRYKER TECHNICIAN COULD NOT DUPLICATE THE EVENT. THE UNIT MET AND PERFORMED TO SPECIFICATIONS. NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 17188 | PRIME BIG WHEEL STRETCHER, 30" | HOSPITAL WHEELED STRETCHER | FPO | STRYKER MEDICAL | 111500030 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |