FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE
MDR report key: 2072908
·
Received March 31, 2011
Report
- Report Number
- 1824206-2011-01974
- Event Type
- Malfunction
- Date Received
- March 31, 2011
- Date of Event
- March 9, 2011
- Report Date
- March 9, 2011
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- QA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
REPAIRS HAVE NOT BEEN COMPLETED.
Description of Event or Problem · 1
INFO RECEIVED INDICATES THAT THE BED IS IN THE LOW POSITION AND HAS NO FUNCTIONS WORKING AND THE BATTERY LED IS OFF. THE ACCOUNT FOUND THE F17 AND F18 FUSES WERE COMPROMISED. HE REPLACED THE FUSES AND WAS ABLE TO RAISE THE BED BUT FOUND THREE CABLES THAT WERE CUT WITH COPPER WIRES EXPOSED. THE THREE CABLES ARE THE MTS CABLE, THE RIGHT HEAD SIDERAIL DETECTION CABLE AND SWITCH AND THE RIGHT HEAD SIDERAIL CABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTALCARE | AC-POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 1900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |