BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTALCARE BED

    MDR report key: 4943377 · Received July 22, 2015

    Report

    Report Number
    1824206-2015-00742
    Event Type
    Injury
    Date Received
    July 22, 2015
    Date of Event
    June 23, 2015
    Report Date
    June 23, 2015
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    PMA / PMN Number
    K962942
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN FOUND AN AIR LEAK IN THE MANIFOLD AND AN ERROR WITH THE AIR CONTROL BOARD. THE TECHNICIAN REPLACED THE MANIFOLD, AIR CONTROL BOARD AND CABLING TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED. 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 PREVENTATIVE MAINTENANCE ON THEIR BEDS. THE PATIENT'S MOTHER STATED THE PATIENT IS A QUADRIPLEGIC AND IS ALSO IN A WHEEL CHAIR FOR 8-9 HOURS A DAY. SHE FEELS THE COMBINATION OF THE USE OF THE WHEEL CHAIR AND THE MATTRESS NOT WORKING CONTRIBUTED TO THE WOUNDS.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING THE AIR MATTRESS IS ALARMING AND NOT WORKING PROPERLY AND THE PATIENT HAS DEVELOPED NEW SORES ON HIS BACK SIDE AND SHOULDER BLADES, ONE OF WHICH IS A STAGE 3 SORE. THE PATIENT IS BEING TREATED WITH DRESSINGS AND A WOUND VAC FOR THE STAGE 3. THE BED IS LOCATED IN THE PATIENT'S HOME. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475149 TOTALCARE BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 1900

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other