FDA Adverse Event
Malfunction
Summary report: N
VERSACARE BED
MDR report key: 3881789
·
Received May 27, 2014
Report
- Report Number
- 1824206-2014-01637
- Event Type
- Malfunction
- Date Received
- May 27, 2014
- Date of Event
- May 1, 2014
- Report Date
- May 1, 2014
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE HILL-ROM TECHNICIAN FOUND THE BED HAD A FAULTY LEFT PUSH HANDLE. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS DID NOT SHOW HILL-ROM PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS BED. IT IS UNK IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR BEDS. THE TECHNICIAN REPLACED THE LEFT PUSH HANDLE TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.
Description of Event or Problem · 1
HILL-ROM RECEIVED A REPORT FROM A HILL-ROM TECHNICIAN STATING WHILE TRYING TO MOVE THE BED FORWARD WITH THE INTELLIDRIVE THE BED GOES IN REVERSE. THE BED LOCATED AT THE ACCOUNT IN ENGINEERING. THERE WAS NO PT/USER INJURY REPORTED. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 310709 | VERSACARE BED | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 3200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |