BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIMBUS 4

    MDR report key: 3233357 · Received July 11, 2013

    Report

    Report Number
    1419652-2013-00196
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 5, 2013
    Manufacturer
    GETINGE (SUZHOU) CO. LTD
    Product Code
    FNM
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WE RECEIVED A REPORT ON (B)(6) 2013, WITH A FAULTY NIMBUS 3 SYSTEM - THE MATTRESS WAS DEFLATED BUT THE PUMP WAS NOT ALARMING AND PT SUFFERED HARM AS A RESULT. THE MATTRESS OVERALL IS IN GOOD VISUAL CONDITION BUT HAS SEVERAL LEAKING CELLS. REF. MFR #3005619970-2013-00008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320043 NIMBUS 4 FNM GETINGE (SUZHOU) CO. LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention