FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE
MDR report key: 2182127
·
Received June 23, 2011
Report
- Report Number
- 1824206-2011-03415
- Event Type
- Malfunction
- Date Received
- June 23, 2011
- Date of Event
- June 8, 2011
- Report Date
- June 8, 2011
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN COULD NOT REPLICATE THE FAULT BUT DID FIND A SLIGHT OIL LEAK UNDER THE HEAD HI-LOW CYLINDER. HE REPLACED THE HEAD HI/LOW CYLINDER TO REPAIR THE BED.
Description of Event or Problem · 1
INFORMATION RECEIVED INDICATES THE HEAD OF THE BED IS GOING DOWN ON ITS OWN.
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 |