FDA Adverse Event
Malfunction
Summary report: N
4 MOTOR ADVANCE BED
MDR report key: 1191322
·
Received September 26, 2008
Report
- Report Number
- 1824206-2008-03471
- Event Type
- Malfunction
- Date Received
- September 26, 2008
- Date of Event
- August 20, 2008
- Report Date
- August 20, 2008
- Manufacturer
- HILL-ROM RITTER
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE HOSPITAL BIOMEDICAL TECHNICIAN REPORTED THAT THIS BED HAD HIGH GROUND RESISTANCE WHILE PERFORMING PREVENTIVE MAINTENANCE. HE REPLACED THE AC POWER PLUG TO RESOLVE THE ISSUE. THERE WERE NO REPORTED ADVERSE EVENTS ASSOCIATED WITH THIS PRODUCT PROBLEM. THIS BED IS EQUIPPED WITH A GROUND LOSS INDICATOR TO WARN THE CAREGIVER THAT THERE HAS BEEN A LOSS OF GROUND AND TO MINIMIZE ANY RISK TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 4 MOTOR ADVANCE BED | AC POWERED HOSPITAL BED | FNL | HILL-ROM RITTER | 1135 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |