FDA Adverse Event
Malfunction
Summary report: N
3002 SECURE II
MDR report key: 2191876
·
Received July 29, 2011
Report
- Report Number
- 1831750-2011-07820
- Event Type
- Malfunction
- Date Received
- July 29, 2011
- Date of Event
- July 1, 2011
- Report Date
- July 1, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULT: MISSING MOTION INTERRUPT PAN, DAMAGED POWER CORD, BED EXIT AND SCALE LABELS WERE MISSING.
Description of Event or Problem · 1
IT WAS REPORTED BY SVC REPORT THAT THE MOTION INTERRUPT PAN WAS MISSING; THE POWER CORD WAS DAMAGED, AND BED EXIT AND SCALE LABELS WERE MISSING ON THE FOOTBOARD. IT IS UNK IF THERE WAS PT INVOLVEMENT OR ADVERSE CONSEQUENCES TO REPORT.
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 |