FDA Adverse Event
Malfunction
Summary report: N
VERSACARE BED
MDR report key: 3810382
·
Received April 11, 2014
Report
- Report Number
- 1824206-2014-01158
- Event Type
- Malfunction
- Date Received
- April 11, 2014
- Date of Event
- March 13, 2014
- Report Date
- March 13, 2014
- Manufacturer
- HILL-ROM INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN FOUND THAT THE NURSE CALL FEATURE WAS NOT ENABLED AFTER THE UPPER CONTROL BOARD WAS REPLACED, INSTALLATION ERROR. 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 ENABLED THE NURSE CALL FEATURE TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.
Description of Event or Problem · 1
THE ACCOUNT REPORTED THE NURSE CALL WAS NOT FUNCTIONING. THE BED WAS LOCATED ON THE 4TH FLOOR AT THE FACILITY. THERE WAS NO PT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 221674 | VERSACARE BED | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM INC. | 3200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |