BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAQUET (DATASCOPE CORPORATION)

    MDR report key: 4541617 · Received February 12, 2015

    Report

    Report Number
    MW5040877
    Event Type
    Injury
    Date Received
    February 12, 2015
    Date of Event
    February 7, 2015
    Report Date
    February 11, 2015
    Manufacturer
    MAQUET
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RUPTURE OF AN INTRA AORTIC BALLOON PUMP. DATES OF USE: (B)(6) 2015-(B)(6) 2015. EVENT ABATED AFTER USE STOPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104376 MAQUET (DATASCOPE CORPORATION) CARDIAC ASSIST BALLOON PUMPS (INTRA-AORTIC BALLOON PUMP) DSP MAQUET CS300 CLASS CODE 10-846

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention