FDA Adverse Event
Other
Summary report: N
ULTRACARE ELECTRIC BED
MDR report key: 3142276
·
Received May 24, 2013
Report
- Report Number
- 3009402404-2013-00024
- Event Type
- Other
- Date Received
- May 24, 2013
- Date of Event
- April 18, 2013
- Report Date
- May 22, 2013
- Manufacturer
- JOERNS HEALTHCARE
- Product Code
- FNL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4) IS SENDING THE REPORT TO THE MFR.
Description of Event or Problem · 1
IT WAS REPORTED TO THE MFR BY THE FACILITY (B)(6), PER THE FAMILY MEMBER, THEY WERE LOWERING THE BED AND THE HYDRAULICS GAVE OUT. THE BED CAME DOWN AND SMASHED THE FAMILY MEMBER'S LEFT FOOT. SEVERAL CALLS WERE MADE TO THE FACILITY ON MULTIPLE OCCASIONS WITH NO RESPONSE FROM THE FACILITY. (B)(6), A SERVICE REPAIR COMPANY, WENT TO THE FACILITY ON (B)(6) 2013. (B)(4) PERFORMED A VISUAL INSPECTION AND BED FUNCTION TESTING ON THE BED. THE BED PERFORMED AS INTENDED WITH NO FAILURES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 230538 | ULTRACARE ELECTRIC BED | PATIENT HOSPITAL BED | FNL | JOERNS HEALTHCARE | UCXTBED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |