BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE

    MDR report key: 2033881 · Received March 23, 2011

    Report

    Report Number
    1824206-2011-01795
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 1, 2011
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECH INSPECTED THE BED AND FOUND THE SIDERAILS WERE TILTED IN ON THE TOP DUE TO BENT SIDERAIL MOUNTING BRACKETS. THE LATCHES WERE CONTAMINATED AND THE SIDERAILS WERE IN GENERALLY POOR CONDITION. THE TECH CLEANED AND LUBED THE LATCH PIN AND COULD GET THE SIDERAIL TO LATCH. THE FACILITIES MAINTENANCE DOES NOT HAVE A PREVENTIVE PROGRAM AND THE SIDERAIL WILL NEED TO BE REBUILT TO COMPLETELY REPAIR THE BED. THE TOTALCARE BED SYSTEM SERVICE MANUAL STATES: HILL-ROM RECOMMENDS SEMI-ANNUAL PREVENTIVE MAINTENANCE FOR THE BED. TEST THE SIDERAIL FOR PROPER LATCHING. WHEN THE SIDERAIL IS LATCHED, AN AUDIBLE CLICK SHOULD BE HEARD. GENTLY PULL ON THE SIDERAIL TO MAKE SURE ITS 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.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGED THAT A PT WAS PULLING HIMSELF UP IN BED BY GRABBING BOTH INTERMEDIATE SIDERAILS AND ONE OF THE INTERMEDIATE RAILS DROPPED. THE PT WAS FULLY IN BED AND THERE WAS NO INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTALCARE AC-POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 1900

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK