FDA Adverse Event
Malfunction
Summary report: N
SECURE ACUTE CARE BED
MDR report key: 2141359
·
Received June 1, 2011
Report
- Report Number
- 1831750-2011-05341
- Event Type
- Malfunction
- Date Received
- June 1, 2011
- Date of Event
- May 4, 2011
- Report Date
- May 4, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
RESULT: FOOT BOARD LID, TIMING LINK, HEAD BOARD, RETAINING RING. CONCLUSION: CUSTOMER HAS NOT DECIDED TO REPAIR THE BED AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED BY SVC REPORT THAT THE FOOTBOARD LID WAS BROKEN AND THERE WERE SHARP EDGES, THE RETAINING RINGS WERE MISSING FOR THE FOOT SIDE RAIL SPRINGS, THE HEAD RIGHT TIMING LINK WAS BENT, THE HEADBOARD WAS BROKEN WITH SHARP EDGES, THE WRONG POWER CORD WAS PRESENT. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SECURE ACUTE CARE BED | A/C POWERED HOSPITAL BED | FNL | STRYKER MEDICAL | 3000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |