FDA Adverse Event
Malfunction
Summary report: N
3002 SECURE II
MDR report key: 2232698
·
Received July 19, 2011
Report
- Report Number
- 1831750-2011-07341
- Event Type
- Malfunction
- Date Received
- July 19, 2011
- Date of Event
- June 21, 2011
- Report Date
- June 21, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULT: FAULTY POWER COIL CABLE. BROKEN HEAD-END LIFT MOTOR COUPLER.
Description of Event or Problem · 1
IT WAS REPORTED BY SVC REPORT THAT THE BED WAS STUCK, AND THE HEAD-END COULD NOT ASCEND OR DESCEND TO THE LOWEST POSITION. NO PT 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 |