FDA Adverse Event
Malfunction
Summary report: N
3002 SECURE II
MDR report key: 2141323
·
Received June 1, 2011
Report
- Report Number
- 1831750-2011-05320
- Event Type
- Malfunction
- Date Received
- June 1, 2011
- Date of Event
- May 4, 2011
- Report Date
- May 4, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULT: MALFUNCTIONING CLUTCH ASSEMBLY. DAMAGED HEAD-END OUTER SIDERAIL PANELS.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE FOWLER MOTOR WAS DRIFTING DOWN WITH WEIGHT; THE HEAD-END SIDERAIL OUTER PANELS WERE STRUCTURALLY CRACKED WITH NO SHARP EDGES. THE FOOTBOARD SCALE AND STANDARD MODULES WERE CRACKED BUT STILL FUNCTIONAL. NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3002 SECURE II | A/C POWERED HOSPITAL BED | FNL | STRYKER MEDICAL | 3002 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |