FDA Adverse Event
Malfunction
Summary report: N
ADVANTA BED
MDR report key: 3952204
·
Received May 13, 2014
Report
- Report Number
- 1824206-2014-01475
- Event Type
- Malfunction
- Date Received
- May 13, 2014
- Date of Event
- April 15, 2014
- Report Date
- April 15, 2014
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN FOUND THE SCALE POWER CONTROL BOARD WAS NOT FUNCTIONING. THE MOST LIKELY CAUSE IS NORMAL WEAR AND TEAR. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2010 THROUGH 2013. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED THE SCALE POWER CONTROL BOARD ASSEMBLY TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.
Description of Event or Problem · 1
THE ACCOUNT REPORTED THE BED EXIT ALARM VOLUME IS TOO LOW. THE BED WAS LOCATED IN THE BED SHOP AT THE FACILITY. THERE WAS NO PATIENT/USER INJURY REPORTED. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 285517 | ADVANTA BED | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 1600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |