FDA Adverse Event
Malfunction
Summary report: N
VERSACARE FRAME
MDR report key: 5019244
·
Received August 20, 2015
Report
- Report Number
- 1824206-2015-00830
- Event Type
- Malfunction
- Date Received
- August 20, 2015
- Date of Event
- July 29, 2015
- Report Date
- July 29, 2015
- Manufacturer
- HILL-ROM BATESVILLE
- Product Code
- FNK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE HILL-ROM TECHNICIAN FOUND THE EXTERNAL ALARM WAS FAULTY FOR THIS DEVICE. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2011-2014. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED THE EXTERNAL ALARM TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.
Description of Event or Problem · 1
HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING THE BED ALARM HAD NO SOUND. THE BED WAS LOCATED AT THE ACCOUNT. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 550889 | VERSACARE FRAME | A/C POWERED ADJUSTABLE HOSPITAL BED | FNK | HILL-ROM BATESVILLE | 3200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |