BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE BED

    MDR report key: 4213250 · Received October 3, 2014

    Report

    Report Number
    1824206-2014-02398
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    PMA / PMN Number
    K122473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    HILL-ROM TECHNICAL SUPPORT FOUND THE SCALE BOARD TO BE INOPERABLE. 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 PREVENTIVE MAINTENANCE ON THEIR BEDS. THE ACCOUNT REPLACED THE SCALE BOARD TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING THE BED SCALE WAS NOT READING CORRECTLY. THE BED WAS LOCATED AT THE ACCOUNT. THERE WAS NO PATIENT/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
    620969 TOTALCARE BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 1900

    Patients

    Seq Age Sex Outcome Treatment
    1