FDA Adverse Event
Malfunction
Summary report: N
STAIR PRO-MODEL 6252
MDR report key: 2830410
·
Received October 10, 2012
Report
- Report Number
- 1831750-2012-10587
- Event Type
- Malfunction
- Date Received
- October 10, 2012
- Date of Event
- September 10, 2012
- Report Date
- September 11, 2012
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FPP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
STAIR CHAIR TRACKS. THE UNIT WAS EVALUATED BY THE CUSTOMER AND RETURNED TO STRYKER.
Description of Event or Problem · 1
IT IS REPORTED THAT THE CHAIR SEEMED TO NOT HAVE BEEN FUNCTIONING AND PICKING UP UNCONTROLLABLE SPEED DOWN THE STAIR WAY. THERE WAS PATIENT INVOLVEMENT BUT NO ADVERSE CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STAIR PRO-MODEL 6252 | STRETCHER, HAND-CARRIED | FPP | STRYKER MEDICAL | 6252 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |