FDA Adverse Event
Malfunction
Summary report: N
3002 SECURE II
MDR report key: 2251848
·
Received August 10, 2011
Report
- Report Number
- 1831750-2011-08433
- Event Type
- Malfunction
- Date Received
- August 10, 2011
- Date of Event
- July 13, 2011
- Report Date
- July 13, 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 - CRACKED PATIENT HEAD LEFT OUTER SIDERAIL PANEL WITH SHARP EDGES. FAULTY POWER CORD.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE PATIENT HEAD LEFT OUTER SIDERAIL PANEL WAS CRACKED WITH SHARP EDGES, AND THE POWER CORD RESISTANCE WAS TOO HIGH. IT IS UNKNOWN IF 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 |