FDA Adverse Event
Malfunction
Summary report: N
VERSACARE BED
MDR report key: 3896289
·
Received May 19, 2014
Report
- Report Number
- 1824206-2014-01535
- Event Type
- Malfunction
- Date Received
- May 19, 2014
- Date of Event
- April 21, 2014
- Report Date
- April 21, 2014
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN FOUND THAT THE EXTERNAL BUZZER WAS NOT FUNCTIONING; THE TECHNICIAN DID NOT KNOW THE CAUSE OF THE BUZZER NOT FUNCTIONING. THE TECHNICIAN REPLACED THE EXTERNAL ALARM WITH HOUSING TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.
Description of Event or Problem · 1
THE ACCOUNT REPORTED THAT THE BED EXIT ALARM AND THE BRAKE NO SET ALARM HAVE NO AUDIBLE ALARM SOUND. THE BED WAS LOCATED IN THE TRAINING ROOM AT THE FACILITY. THERE WAS NO PATIENT/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 |
|---|---|---|---|---|---|---|---|
| 297913 | VERSACARE BED | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 3200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |