FDA Adverse Event
Malfunction
Summary report: N
3002 SECURE II
MDR report key: 2231505
·
Received July 22, 2011
Report
- Report Number
- 1831750-2011-07495
- Event Type
- Malfunction
- Date Received
- July 22, 2011
- Date of Event
- June 26, 2011
- Report Date
- June 26, 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
SCALE MODULE MALFUNCTION. POWER CORD WAS CUT.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE SCALE WAS INOPERABLE, WITH THE DISPLAY MODULE DIFFICULT TO READ, AND THE POWER CORD WAS CUT, WITH NO BARE WIRES EXPOSED. 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 |