FDA Adverse Event Malfunction Summary report: N

ADVANTA BED

MDR report key: 3883280 · Received February 20, 2014

Report

Report Number
1824206-2014-00531
Event Type
Malfunction
Date Received
February 20, 2014
Date of Event
January 22, 2014
Report Date
January 22, 2014
Manufacturer
HILL-ROM INC.
Product Code
FNL
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
NC, US
Reporter Occupation
UNKNOWN

Narratives

Additional Manufacturer Narrative · 1

THE TECHNICIAN FOUND THE BRAKES ARE OUT OF ADJUSTMENT. THIS MAY BE DUE TO NORMAL WEAR AND TEAR. PER THE HILL-ROM SERVICE MANUAL THE ADVANTA BED REQUIRES AN EFFECTIVE MAINTENANCE PROGRAM. PREVENTATIVE MAINTENANCE WILL MINIMIZE DOWNTIME DUE TO EXCESSIVE WEAR. TEST THE BRAKE CASTERS TO DETERMINE IF THE BED MOVES WHEN YOU ACTIVATE THE BRAKE MODE. TEST THE STEER MODE TO DETERMINE IF THE FOOT END CASTERS LOCK IN THE STEER MODE. CHECK THE TIRES FOR CUTS, WEAR, TREAD LIFE, ETC. THE TECHNICIAN ADJUSTED THE BRAKE CASTERS TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.

Description of Event or Problem · 1

THE ACCOUNT REPORTED THE BRAKE WOULD NOT FULLY ENGAGE WHEN THE BRAKE IS APPLIED. THE BED IS LOCATED ON THE 3RD FLOOR AT THE FACILITY. THERE WAS NO PT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
107214 ADVANTA BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM INC. 1600

Patients

Seq Age Sex Outcome Treatment
1