BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECONDITIONED TOTALCARE BED

    MDR report key: 5016128 · Received August 19, 2015

    Report

    Report Number
    1824206-2015-00821
    Event Type
    Malfunction
    Date Received
    August 19, 2015
    Date of Event
    July 24, 2015
    Report Date
    July 24, 2015
    Manufacturer
    HILL-ROM INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BIOMEDICAL ENGINEER FOUND THE BRAKE CASTER WAS WORN. PER THE HILL-ROM SERVICE MANUAL THE TOTALCARE BED SYSTEM REQUIRES AN EFFECTIVE MAINTENANCE PROGRAM. WE RECOMMEND THAT YOU PERFORM A SEMI-ANNUAL PREVENTATIVE MAINTENANCE. PREVENTATIVE MAINTENANCE WILL MINIMIZE DOWNTIME DUE TO EXCESSIVE WEAR. TEST THE BRAKE CASTERS TO DETERMINE IF THE BED MOVES WHEN YOU ACTIVATE THE BRAKE, REPLACE OR ADJUST WHEN NECESSARY. CHECK THE TIRES FOR CUTS, WEAR, TREAD LIFE, ETC. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS DID NOT SHOW HILL-ROM PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS BED. IT IS UNKNOWN IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR BEDS. THE BIOMEDICAL ENGINEER REPLACED THE BRAKE CASTER TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT STATING, "THE CASTER ROLLS AND SWIVELS WHEN LOCKED INTO BRAKE. PEDAL IS WORKING, CASTER WILL NOT LOCK." THERE WAS NO PATIENT OR USER INJURY RELATED TO THIS COMPLAINT. THIS COMPLAINT HAS BEEN DOCUMENTED IN OUR COMPLAINT HANDLING SYSTEM AS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548835 RECONDITIONED TOTALCARE BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM INC.

    Patients

    Seq Age Sex Outcome Treatment
    1