FDA Adverse Event
Malfunction
Summary report: N
EVACUATION CHAIR-MODEL 6253
MDR report key: 2830434
·
Received October 10, 2012
Report
- Report Number
- 1831750-2012-10647
- Event Type
- Malfunction
- Date Received
- October 10, 2012
- Date of Event
- September 12, 2012
- Report Date
- September 12, 2012
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FPP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
LOCK MECHANISM STRUT.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE LOCK MECHANISM STRUT WAS BROKEN WITH SHARP EDGES. THERE WAS PATIENT INVOLVEMENT BUT THE CUSTOMER DID NOT KNOW IF THERE WERE ANY ADVERSE CONSEQUENCES TO REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EVACUATION CHAIR-MODEL 6253 | STRETCHER, HAND-CARRIED | FPP | STRYKER MEDICAL | 6253 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |