BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CS300

    MDR report key: 3872038 · Received April 17, 2014

    Report

    Report Number
    2249723-2014-00408
    Event Type
    Injury
    Date Received
    April 17, 2014
    Date of Event
    January 27, 2013
    Report Date
    January 27, 2013
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE IABP SHUTDOWN WAS ATTRIBUTED TO THE CLOGGED INTAKE VALVE. THIS INDICATES THE IABP WAS OT MAINTAINED PROPERLY. THE CUSTOMER DID NOT HAVE PREVENTATIVE MAINTENANCE AGREEMENT WITH MAQUET. THE COMPANY REPRESENTATIVE REPLACED THE POWER SUPPLY (PART NUMBER 0014-00-0033E05) AND INSTALLED THE 2500 HOUR PUMP REBUILD KIT (PART NUMBER 0040-00-0146) AS A PART OF PREVENTATIVE MAINTENANCE. ALL FUNCTIONAL AND SAFETY TESTS WERE PERFORMED. THE SPECIFICATIONS WERE MET. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE IABP WAS IN USE ON A PATIENT, THE IABP SHUTDOWN AND WILL NOT TURN ON. THE PATIENT WAS SWITCHED TO ANOTHER IABP AND THERAPY CONTINUED. NO PATIENT INJURY WAS REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235550 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS300

    Patients

    Seq Age Sex Outcome Treatment
    1 Other