FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE BED
MDR report key: 3102096
·
Received April 23, 2013
Report
- Report Number
- 1824206-2013-02330
- Event Type
- Malfunction
- Date Received
- April 23, 2013
- Date of Event
- March 27, 2013
- Report Date
- March 27, 2013
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE ACCOUNT REPLACED BOTH USER CONTROL MODULE CABLES AND USER CONTROL MODULE BOARDS TO RESOLVE THE ISSUE.
Description of Event or Problem · 1
THE ACCOUNT ALLEGED THAT THE BED HAD NO NURSE CALL FROM EITHER SIDE RAIL. NO PT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 174503 | TOTALCARE BED | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 1900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |