BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTO LOGIC

    MDR report key: 3111205 · Received April 19, 2013

    Report

    Report Number
    1419652-2013-00099
    Event Type
    Injury
    Date Received
    April 19, 2013
    Date of Event
    March 22, 2013
    Report Date
    March 22, 2013
    Manufacturer
    GETINGE (SUZHOU) CO. LTD
    Product Code
    FNM
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    TWO UNINFLATED CELLS BECAUSE OF TWISTING, RESULTING IN PRESSURE TRACES ON THE BACK OF A PT. NO ALARM. MFR REF #3005619970-2013-00005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170726 AUTO LOGIC PAC FNM GETINGE (SUZHOU) CO. LTD PXB001ADV

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention