BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 11526031 · Received March 19, 2021

    Report

    Report Number
    2249723-2021-00559
    Event Type
    Malfunction
    Date Received
    March 19, 2021
    Date of Event
    February 19, 2021
    Report Date
    April 27, 2021
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567107882
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A ROUTINE CHECK, A VIBRATION WAS EMITTING FROM THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.

    Additional Manufacturer Narrative · 1

    A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO INVESTIGATE. THE FSE TESTED THE IABP UNIT ON TRAINER AND BALLOON FOR TWO HOURS, AND DID NOT OBSERVE NOISE COMING FROM THE MOTOR COMPARTMENT. HOWEVER, THE FSE OBSERVED VIBRATION EVERY 20-30 MINUTES COMING FROM THE MOTOR. UPON REMOVING THE MOTOR COMPARTMENT, THE FSE DISCOVERED THE MOTOR MOUNT TORN FROM THE MANIFOLD SIDE, AS WELL AS THE MOTOR OUT OF BALANCE WHICH COULD HAVE CAUSED THE MOTOR MOUNT TO TEAR. THE FSE RESOLVED THE ISSUE BY REPLACING THE MOTOR ASSEMBLY AND MOTOR MOUNTS. THE FSE THEN PERFORMED ALL FUNCTIONAL AND SAFETY CHECKS TO MEET FACTORY SPECIFICATIONS. THE IABP WAS THEN RELEASED TO THE CUSTOMER AND CLEARED FOR CLINICAL SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE CHECK, A VIBRATION WAS EMITTING FROM THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420244 CS300 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH N/A N/A 10607567107882

    Patients

    Seq Age Sex Outcome Treatment
    1