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