BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET

    MDR report key: 2514332 · Received March 28, 2012

    Report

    Report Number
    MW5024846
    Event Type
    Malfunction
    Date Received
    March 28, 2012
    Date of Event
    March 28, 2012
    Report Date
    March 28, 2012
    Manufacturer
    DATASCOPE
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED TO (B)(6) ON (B)(6) 2012 WITH STEMI TO CATH LAB ON (B)(6) 2012, WHEN INTRA OPERATIVE BALLOON WAS INSERTED VIA RIGHT FEMORAL ARTERY FOR CABG (B)(6) 2012. AT 12 MN (B)(6) 2012, BLOOD WAS NOTES IN BALLOON PROXIMAL TO FEMORAL INSERTION SITE. PA AND CARDIOLOGIST NOTIFIED AND IAB PULLED AT SA WITHOUT DIFFICULTY OR HARM TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAQUET INTRA AORTIC BALLOON DSP DATASCOPE REF#068600047901

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR