FDA Adverse Event
Malfunction
Summary report: N
VERSACARE BED
MDR report key: 5008388
·
Received August 11, 2015
Report
- Report Number
- 1824206-2015-00801
- Event Type
- Malfunction
- Date Received
- August 11, 2015
- Date of Event
- July 20, 2015
- Report Date
- July 20, 2015
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE HILL-ROM TECHNICIAN FOUND THE NURSE CALL CABLE DAMAGED. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS DID NOT SHOW HILL-ROM PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS BED. IT IS UNKNOWN IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR BEDS. THE TECHNICIAN REPLACED THE NURSE CALL CABLE TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.
Description of Event or Problem · 1
HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING THE NURSE CALL WAS INOPERATIVE. THE BED WAS LOCATED AT THE ACCOUNT. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 524202 | VERSACARE BED | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 3200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |