FDA Adverse Event Malfunction Summary report: N

VERSACARE BED

MDR report key: 3223885 · Received July 2, 2013

Report

Report Number
1824206-2013-03299
Event Type
Malfunction
Date Received
July 2, 2013
Date of Event
June 5, 2013
Report Date
June 5, 2013
Manufacturer
HILL-ROM, INC.
Product Code
FNL
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
CA
Reporter Occupation
UNKNOWN

Narratives

Additional Manufacturer Narrative · 1

THE TECHNICIAN FOUND THE SIDE RAIL CENTER ARM WAS BROKEN RIGHT OFF OF THE BED FRAME AND HANGING FROM THE SIDE RAIL FRAME. MAJOR IMPACT TO BREAK THE PLASTIC HOUSING IS EVIDENT. THE TECHNICIAN REPLACED THE SIDE RAIL CENTER ARM ASSEMBLY TO RESOLVE ISSUE WITH BED.

Description of Event or Problem · 1

THE ACCOUNT ALLEGED THE SIDE RAIL IS NOT LATCHING. NO PT IMPACT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
301513 VERSACARE BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 3200

Patients

Seq Age Sex Outcome Treatment
1