FDA Adverse Event
Malfunction
Summary report: N
SECURE 2 MED/SURGBED
MDR report key: 2061901
·
Received March 18, 2011
Report
- Report Number
- 1831750-2011-02596
- Event Type
- Malfunction
- Date Received
- March 18, 2011
- Date of Event
- February 24, 2011
- Report Date
- February 24, 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: SIDERAIL WELDMENT ASSEMBLY; MOTION INTERRUPT PAN.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE LEFT SIDE RAIL WOULD NOT LOCK IN THE UPRIGHT POSITION AND THE MOTION INTERRUPT PAN IS MISSING. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SECURE 2 MED/SURGBED | A/C POWERED HOSP BED | FNL | STRYKER MEDICAL | 3002 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |