FDA Adverse Event Malfunction Summary report: N

ADVANCE BED

MDR report key: 3843732 · Received February 12, 2014

Report

Report Number
1824206-2014-00405
Event Type
Malfunction
Date Received
February 12, 2014
Date of Event
January 15, 2014
Report Date
January 15, 2014
Manufacturer
HILL-ROM, INC.
Product Code
FNL
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
CA, US
Reporter Occupation
OTHER

Narratives

Additional Manufacturer Narrative · 1

THE TECHNICIAN FOUND THE BRAKE CASTER AND BRAKE STEER CASTER ARE THE CAUSE. PER THE HILL-ROM SERVICE MANUAL THE ADVANCE SERIES BED REQUIRES EFFECTIVE MAINTENANCE PROGRAM. PREVENTATIVE MAINTENANCE WILL MINIMIZE DOWNTIME DUE TO EXCESSIVE WEAR. CHECK THE TIRES FOR CUTS, WEAR, TREAD LIFE, ETC. TEST THE BRAKE CASTERS TO DETERMINE IF THE BED MOVES WHEN YOU ACTIVATE THE BRAKE MODE, REPLACE OR ADJUST WHEN NECESSARY. THE TECHNICIAN REPLACED THE BRAKE CASTER AND STEER CASTER TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.

Description of Event or Problem · 1

THE ACCOUNT REPORTED THE BED STILL ROLLS WHILE IN BRAKE MODE. THE BED IS LOCATED IN THE WAREHOUSE OF THE FACILITY. THERE WAS NO PT/USER INJURY REPORTED. (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
92491 ADVANCE BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 1165

Patients

Seq Age Sex Outcome Treatment
1