FDA Adverse Event
Malfunction
Summary report: N
SECURE 2 MED/SURGBED
MDR report key: 2033365
·
Received March 22, 2011
Report
- Report Number
- 1831750-2011-02677
- Event Type
- Malfunction
- Date Received
- March 22, 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
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULT: SIDERAIL TIMING LINK; SIDERAIL PANEL.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE RIGHT TIMING LINK SNAPPED IN HALF ON THE BLACK TIMING BAR RAIL AND WOULD LOCK IN THE UPPER POSITION IF YOU WORKED IT. ONE SET OF INNER AND OUTER ARMS COVERS MISSING ON THE LEFT RAIL. NO PATIENT 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 HOSPITAL BED | FNL | STRYKER MEDICAL | 3002 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |