BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DATASCOPE

    MDR report key: 3896651 · Received June 6, 2014

    Report

    Report Number
    3896651
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    April 17, 2014
    Report Date
    June 6, 2014
    Manufacturer
    MAQUET DATASCOPE CORP - CARDIAC ASSIST DIVISION
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US

    Narratives

    Description of Event or Problem · 1

    RECEIVED ALERT FROM IABP DEVICE THAT THERE WAS AN AIR LEAK IN THE CIRCUIT. THE STAFF CONFIRMED THAT THERE WERE NO LOOSE CONNECTIONS. THE DEVICE WAS REBOOTED AND ALARMED "ELECTRICAL FAULT NO.53". THE PUMP WAS CHANGED OUT AND NO ALERT REGARDING AIR IN CIRCUIT WAS SUBSEQUENTLY RECEIVED. THERE WAS NO HARM TO THE PATIENT.THE MANUFACTURER RESPONDED TO THE LOCATION AND REPAIRED AN INTERMITTENT CONTACT WITH THE ABSOLUTE PRESSURE TRANSDUCER CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331601 DATASCOPE SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP MAQUET DATASCOPE CORP - CARDIAC ASSIST DIVISION 403072279 *

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR