BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL CARE BARIATRIC BED

    MDR report key: 3940768 · Received April 22, 2014

    Report

    Report Number
    1824206-2014-01276
    Event Type
    Malfunction
    Date Received
    April 22, 2014
    Date of Event
    March 29, 2014
    Report Date
    March 29, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    PMA / PMN Number
    K122473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN THOROUGHLY TESTED AND INSPECTED THE BED AND FOUND NO ISSUES. THE HEAD OF THE BED FUNCTIONED AS DESIGNED. PER THE HILL-ROM SERVICE MANUAL THE TOTAL CARE 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 BED FUNCTION CONTROLS FOR PROPER OPERATION OF THE FUNCTION AND MOMENTARY OPERATION. TEST ALL LOCKOUT CONTROLS AND INDIVIDUALLY CHECK FOR PROPER OPERATION. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS DID NOT SHOW HILL-ROM PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS BED. IT IS UNK IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR BEDS. THE HILL-ROM SERVICE TECHNICIAN PROVIDED AN INSERVICE ON THE BED OPERATIONS. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING THE HEAD SECTION OF THE BED MOVED UP WHEN IN THE THERAPY MODE. THE BED WAS LOCATED AT THE ACCOUNT. THERE WAS NO PT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242650 TOTAL CARE BARIATRIC BED A/C POWERD ADJUSTABEL HOSPITAL BED FNL HILL-ROM, INC. 1840

    Patients

    Seq Age Sex Outcome Treatment
    1