FDA Adverse Event
Malfunction
Summary report: N
CAREASSIST BED
MDR report key: 3883974
·
Received February 14, 2014
Report
- Report Number
- 9615739-2014-00048
- Event Type
- Malfunction
- Date Received
- February 14, 2014
- Date of Event
- January 16, 2014
- Report Date
- January 16, 2014
- Manufacturer
- HILL-ROM PLUVIGNER
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN FOUND BENT PINS ON THE COMMUNICATION CABLE. THIS DAMAGE OCCURS DUE TO ABUSE OR INSTALLATION ERROR BY THE ACCOUNT. THE TECHNICIAN REPLACED THE COMMUNICATION CABLE TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.
Description of Event or Problem · 1
THE TECHNICIAN REPORTED THE BED IS NOT COMMUNICATING WITH THE NURSE CALL SYSTEM. THERE WAS NO PATIENT/USER INJURY REPORTED. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 98399 | CAREASSIST BED | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM PLUVIGNER | 1170 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |