BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 4004887 · Received July 23, 2014

    Report

    Report Number
    2249723-2014-01044
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    March 12, 2012
    Report Date
    March 12, 2012
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE FOUND THE PUMP INTERMITTENTLY DISPLAYING MAINTENANCE CODE #7 (POWER SUPPLY FAN FAILURE) EVEN THOUGH THE FAN AS RUNNING. AFTER THE PUMP WAS ON FOR ABOUT A MINUTE ON AC POWER, THE PUMP SHUT OFF. THIS HAPPENED ON AC POWER AND BATTERY. REPLACED THE POWER SUPPLY (P/N 0014-00-0033-05). THE IABP WAS TESTED TO FACTORY SPECIFICATION. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. THE FAILURE MODE OF SUDDEN SHUT DOWN WAS EVALUATED BY MAQUET. THE FAILURE WAS ATTRIBUTED TO A MECHANICAL FAILURE OF THE COOLING FAN OF THE POWER SUPPLY. AS A RESULT OF THIS FAILURE, THE POWER SUPPLY OVERHEATS AND SHUTS DOWN WITHOUT ANY VISUAL OR AUDIBLE WARNING. MAQUET CARDIOVASCULAR LLC HAS INITIATED RECALL 2249723-2/24/2014-001C TO ADDRESS THIS FAILURE MODE. THE FDA (B)(4) DISTRICT RECALL COORDINATOR HAS BEEN ADVISED. A NOTIFICATION LETTER HAS BEEN SENT TO THIS CUSTOMER. HEALTH HAZARD EVALUATION (HHE) WAS CONDUCTED. THE OVERALL RISK OF THE MALFUNCTION IS MODERATE TO HIGH. THE CAPA WAS CLOSED AND ALL CORRECTIVE ACTIONS HAVE BEEN ADDRESSED. (B)(4).

    Description of Event or Problem · 1

    DURING A ROUTINE CHECK OF THE IABP, THE COMPANY REPRESENTATIVE OBSERVED THAT THE IABP GENERATED MAINTENANCE REQUIRED CODE #7 ALARM "POWER SUPPLY FAN FAILURE". NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430023 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS300

    Patients

    Seq Age Sex Outcome Treatment
    1