BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE BED

    MDR report key: 3931701 · Received April 14, 2014

    Report

    Report Number
    1824206-2014-01182
    Event Type
    Malfunction
    Date Received
    April 14, 2014
    Date of Event
    March 17, 2014
    Report Date
    March 17, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    PMA / PMN Number
    K962942
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN INVESTIGATED AND FOUND THE CAUSE WAS DUE TO THE SIDE COM CABLE BEING DEFECTIVE. THE SIDE COM CABLE HAD NOT BEEN RECORDED AS REPLACED AND THE BED WAS DELIVERED TO THE ACCOUNT IN 2008. THE SIDE COM CABLE WAS MOST LIKELY WORN FROM NORMAL WEAR AND TEAR. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2011 THROUGH 2014. IT IS UNK IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE SIDE COM CABLE WAS REPLACED TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE TECH REPORTED THAT THE BED EXIT ALARM ON THE BED WOULD NOT ALARM AT THE BED BUT DID PLACE A CALL TO THE NURSE'S STATION. THE BED WAS LOCATED IN THE BED SHOP AT THE FACILITY. 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
    228869 TOTALCARE BED A/C POWERED ADJUSTABLE HOSP BED FNL HILL-ROM, INC. 1900

    Patients

    Seq Age Sex Outcome Treatment
    1