BEUDAMED
    FDA Adverse Event Death Summary report: N

    AUTO LOGIC

    MDR report key: 3553869 · Received December 27, 2013

    Report

    Report Number
    1419652-2013-00375
    Event Type
    Death
    Date Received
    December 27, 2013
    Date of Event
    November 27, 2013
    Report Date
    December 2, 2013
    Manufacturer
    GETINGE (SUZHOU) CO, LTD
    Product Code
    FNM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WE HAVE BEEN INFORMED ON (B)(6) THAT PT DEVELOPED PRESSURE ULCERS (GRADE 2) AFTER USE OF AUTO LOGIC DEFECTIVE MATTRESS. DURING PT ADMISSION TO THE HOSP THE SLIGHT REDNESS ON THE PT SKIN WAS OBSERVED; PT WAS TRANSFERRED TO A DYNAMIC AUTO LOGIC MATTRESS ((B)(6) 2013). IN THE EVENING, IT WAS FOUND BY MEDICAL STAFF THAT THE PT WAS BOTTOMING DIRECTLY ON THE BED FRAME DUE TO LOSS OF AIR IN THE MATTRESS. THE HOSPITAL STAFF CHANGED THE PUMP, HOWEVER, THE SYSTEM FAILED AGAIN AND THE REDNESS ON THE PT'S BACK DEVELOPED INTO A PRESSURE ULCER (2 DEGREE). AFTER THE INCIDENT, THE ARJOHUNTLEIGH SALES CONSULTANT REVISITED THE FACILITY ((B)(6) 2013) AND WAS INFORMED THAT IN THE MEANTIME PT HAD PASSED AWAY ((B)(6) 2013). THE DEATH CAUSE OF THE PT WAS PULMONARY EDEMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677404 AUTO LOGIC FNM GETINGE (SUZHOU) CO, LTD 630004DK

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Death