FDA Adverse Event
Malfunction
Summary report: N
ELECTRIC MED/SURG BED
MDR report key: 2191696
·
Received July 1, 2011
Report
- Report Number
- 1831750-2011-06733
- Event Type
- Malfunction
- Date Received
- July 1, 2011
- Date of Event
- May 25, 2011
- Report Date
- June 3, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CI
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SHARP EDGES ON CRACKED HEADBOARD.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT A CRACK WAS FOUND IN BOTH SIDES OF THE HEADBOARD. THERE WAS PATIENT INVOLVEMENT BUT NO REPORTED ADVERSE CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ELECTRIC MED/SURG BED | A/C HOSPITAL BED | FNL | STRYKER MEDICAL | FL23SE | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |