FDA Adverse Event
Malfunction
Summary report: N
VERSACARE BED
MDR report key: 3896721
·
Received May 20, 2014
Report
- Report Number
- 1824206-2014-01602
- Event Type
- Malfunction
- Date Received
- May 20, 2014
- Date of Event
- April 28, 2014
- Report Date
- April 28, 2014
- Manufacturer
- HILL-ROM INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE HILL-ROM TECHNICAL SUPPORT SUGGESTED TRYING ZEROING THE SCALE WITH NO PT IN THE BED. SERIAL NUMBER WAS NOT PROVIDED BY THE ACCOUNT FOR PM RECORDS. THREE ATTEMPTS HAVE BEEN MADE BY HILL-ROM TECHNICAL SUPPORT REGARDING A RESOLUTION TO THIS CONTACT LINE, WITH NO RESPONSE. 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 EXIT WOULD NOT SET. THE BED WAS LOCATED IN THE MED SURGE DEPARTMENT AT THE ACCOUNT. THERE WAS NO PT/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 |
|---|---|---|---|---|---|---|---|
| 299183 | VERSACARE BED | AC POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM INC. | 3200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |