FDA Adverse Event
Malfunction
Summary report: N
BASIC CONFIGURATION MODEL 6100 BASE
MDR report key: 1921886
·
Received December 7, 2010
Report
- Report Number
- 1831750-2010-04568
- Event Type
- Malfunction
- Date Received
- December 7, 2010
- Date of Event
- November 25, 2010
- Report Date
- November 25, 2010
- Manufacturer
- STRYKER CORP., MEDICAL DIVISION
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
OTHER: STEERING SYSTEM.
Description of Event or Problem · 1
IT WAS REPORTED BY THE CUSTOMER THAT STEERING SYSTEM OF THE COT WAS IMPOSSIBLE TO MOVE. IT WAS ALSO REPORTED THAT DURING CALIBRATION THE SHOULDER BOLT OF THE BALL PLUNGER WAS DAMAGED. NO ADVERSE CONSEQUENCES OR INJURIES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BASIC CONFIGURATION MODEL 6100 BASE | STRETCHER, WHEELED | FPO | STRYKER CORP., MEDICAL DIVISION | 6100BASICBASE | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |