BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL CARE BED

    MDR report key: 3823242 · Received February 27, 2014

    Report

    Report Number
    1824206-2014-00637
    Event Type
    Malfunction
    Date Received
    February 27, 2014
    Date of Event
    January 30, 2014
    Report Date
    January 30, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND THE LOCKING PIN IN THE SIDE RAIL MOUNTING BRACKET WAS FLATTENED PREVENTING THE SIDE RAIL FROM BEING ABLE TO LATCH WHEN RAISED DUE TO NORMAL WEAR AND TEAR. 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 SIDE RAIL FOR PROPER LATCHING. WHEN THE SIDE RAIL IS LATCHED, AN AUDIBLE CLICK SHOULD BE HEARD. GENTLY PULL ON THE SIDE RAIL TO MAKE SURE IT IS LATCHED PROPERLY. IF LATCHING IS DIFFICULT, MAKE SURE THAT THE LATCH IS CLEAN AND INSPECT FOR OBSTRUCTIONS. IF WEAR IS FOUND, REPLACE THE LATCH COMPONENTS. A SEARCH OF HILL-ROM PREVENTATIVE MAINTENANCE RECORDS DID SHOW THAT PREVENTATIVE MAINTENANCE HAD BEEN PERFORMED IN 2008. HILL-ROM IS NOT AWARE IF THE ACCOUNT HAS PERFORMED ANY PREVENTATIVE MAINTENANCE OTHER THAN 2008 RECORD. THE TECHNICIAN REPLACED THE LEFT FOOT SIDE RAIL MOUNTING BRACKET TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE TECHNICIAN REPORTED THE LEFT FOOT SIDE RAIL WOULD NOT LATCH. THE BED WAS LOCATED IN THE BED SHOP AT THE FACILITY. THERE WAS NO PT/USER INJURY REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122590 TOTAL CARE BED A/C POWERED ADJUSTABLE HOSP BED FNL HILL-ROM, INC. 1900

    Patients

    Seq Age Sex Outcome Treatment
    1