FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE BED
MDR report key: 2823532
·
Received October 8, 2012
Report
- Report Number
- 1824206-2012-06221
- Event Type
- Malfunction
- Date Received
- October 8, 2012
- Date of Event
- September 18, 2012
- Report Date
- September 18, 2012
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER'S MAINTENANCE PERSONNEL STATED THE VALVE PLUNGER RUBBER IS STICKING TO MANIFOLD BLOCK. HILL-ROM TECH SUPPORT WAS TOLD THAT THE FACILITIES MAINTENANCE PERSONNEL WAS GOING TO REPLACE VALVES TO RESOLVE THE ISSUE. THE FACILITY DID NOT WANT FOLLOW UP. THEY STATED THEY WOULD CALL BACK IF THEY NEEDED FURTHER ASSISTANCE.
Description of Event or Problem · 1
CUSTOMER STATED THE HEAD SECTION WOULD NOT RAISE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTALCARE BED | AC POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 1900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |