FDA Adverse Event
Malfunction
Summary report: N
3002 SECURE II
MDR report key: 2191309
·
Received July 28, 2011
Report
- Report Number
- 1831750-2011-07733
- Event Type
- Malfunction
- Date Received
- July 28, 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 - POWER CORD PLUG WITH BENT/CRACKED PRONGS. MISSING MOTION INTERRUPT PAN. BROKEN TABS ON THE SCALE MODULE.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE BED HAD INTERMITTENT POWER; THE POWER CORD HAD A LOOSE/CRACKED PRONG; SCALE MODULES ON FOOTBOARD MOUNTING TABS WERE BROKEN WITH NO SHARP EDGES, AND THE MOTION INTERRUPT PAN WAS MISSING. IT IS UNKNOWN WHETHER THERE WAS PATIENT 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 |