BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAQUET

    MDR report key: 2163618 · Received July 11, 2011

    Report

    Report Number
    MW5021333
    Event Type
    Injury
    Date Received
    July 11, 2011
    Report Date
    July 11, 2011
    Manufacturer
    MAQUET
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MAQUET INTRA-AORTIC BALLOON PUMP WAS PLACED ON (B)(6) 2011 FOR CARDIOGENIC SHOCK. ON (B)(6), IT WAS NOTED THAT THE BALLOON HAD RUPTURED. SHE WAS TAKEN BACK TO THE CATH LAB WHERE THE BALLOON PUMP WAS REMOVED AND A NEW ONE INSERTED. WE HAD A SIMILAR EVENT OCCUR WITH ANOTHER INTRA-AORTIC BALLOON PUMP WHICH WAS INSERTED ON (B)(6) 2011 AND HAD TO BE REPLACED ON (B)(6) 2011. THE DEVICE WAS NOT RETAINED SO NO OTHER PRODUCT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAQUET INTRA-AORTIC BALLOON PUMP DSP MAQUET 2583

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Life Threatening| S