FDA Adverse Event
Malfunction
Summary report: N
BASIC CONFIGURATION MODEL 6100 BASE
MDR report key: 1982317
·
Received January 13, 2011
Report
- Report Number
- 1831750-2011-00462
- Event Type
- Malfunction
- Date Received
- January 13, 2011
- Date of Event
- November 17, 2010
- Report Date
- December 16, 2010
- Manufacturer
- STRYKER CORP., MEDICAL DIV.
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY A TECHNICIAN A FISSURE WAS NOTICED DURING THE UPGRADE OF THE COTS' SLIDE TUBE SUPPORT. THE FISSURE NEVER LEAD TO A FUNCTIONAL DISTURBANCE NOR WAS A PATIENT IMPAIRED. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BASIC CONFIGURATION MODEL 6100 BASE | STRETCHER, WHEELED | FPO | STRYKER CORP., MEDICAL DIV. | 6100 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |