FDA Adverse Event Malfunction Summary report: N

XL BARIATRIC BED

MDR report key: 3882802 · Received February 20, 2014

Report

Report Number
1824206-2014-00559
Event Type
Malfunction
Date Received
February 20, 2014
Date of Event
January 24, 2014
Report Date
January 24, 2014
Manufacturer
HILL-ROM, INC.
Product Code
OSI
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
CA
Reporter Occupation
OTHER

Narratives

Additional Manufacturer Narrative · 1

THE TECH FOUND THAT THE BRAKE/NEUTRAL MECHANISM INSIDE THE BRAKE CASTERS ON BOTH SIDES AT THE HEAD END OF THE BED WERE BROKEN. THE TECH REPLACED THE BRAKE CASTERS TO RESOLVE THE ISSUE BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.

Description of Event or Problem · 1

THE TECH REPORTED THE BRAKES AT THE FOOT END OF THE BED ARE NOT HOLDING. THE BED WAS LOCATED IN THE HILL-ROM SVC CTR. THERE WAS NO PT/USER INJURY REPORTED. (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
107207 XL BARIATRIC BED BARIATRIC BED OSI HILL-ROM, INC. 610B

Patients

Seq Age Sex Outcome Treatment
1