BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 7418252 · Received April 10, 2018

    Report

    Report Number
    2249723-2018-00593
    Event Type
    Malfunction
    Date Received
    April 10, 2018
    Date of Event
    March 20, 2018
    Report Date
    April 10, 2018
    Manufacturer
    DATASCOPE MAHWAH
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTION DEVICE HISTORY RECORD (DHR) FOR THIS IABP UNIT WAS REVIEWED AND NO NON-CONFORMANCES RELATED TO THE REPORTED EVENT WERE NOTED. A GETINGE SERVICE AGENT (GSA) EVALUATED THE IABP AND FOUND THAT THE FAN IN THE CONDENSATE REMOVAL MODULE WAS THE CAUSE OF THE NOISE. THE GSA REPLACED THE CONDENSATE REMOVAL MODULE FROM ANOTHER IABP TO RESOLVE THE ISSUE, AND THE IABP WORKED NORMALLY. THE IABP WAS RETURNED TO CLINICAL USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE CONDENSATE REMOVAL MODULE OF THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) IS VERY NOISY DURING USE. NO ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254195 CS300 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE MAHWAH N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1