FDA Adverse Event
Malfunction
Summary report: N
ADVANTA BED
MDR report key: 3973085
·
Received June 5, 2014
Report
- Report Number
- 1824206-2014-01719
- Event Type
- Malfunction
- Date Received
- June 5, 2014
- Date of Event
- May 8, 2014
- Report Date
- May 8, 2014
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN FOUND THE UNIVERSAL TELEVISION JUNCTION BOX POWER CONTROL BOARD ASSEMBLY WAS NOT FUNCTIONING. THE MOST LIKELY CAUSE IS NORMAL WEAR AND TEAR. 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 UNIVERSAL TELEVISION JUNCTION BOX POWER CONTROL BOARD ASSEMBLY TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.
Description of Event or Problem · 1
THE TECHNICIAN REPORTED THE BED COULD NOT SEND A NURSE CALL. THE BED WAS LOCATED IN PLANT OPERATIONS AT THE FACILITY. THERE WAS NO PT/USER INJURY REPORTED. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 328412 | ADVANTA BED | A/C POWERED ADJUSTABLE HOSP BED | FNL | HILL-ROM, INC. | 1600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |