BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE

    MDR report key: 4093224 · Received August 21, 2014

    Report

    Report Number
    2249723-2014-01243
    Event Type
    Malfunction
    Date Received
    August 21, 2014
    Date of Event
    April 27, 2012
    Report Date
    April 27, 2012
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE PERFORMED FULL FUNCTIONAL CHECK ON THE IABP. THE IABP PASSED ALL TECHNICAL TESTS AND OPERATED WITHOUT ANY ERROR. THE "LOTS OF AIR COMING OUT OF THE VENT" WAS THE AIR MOVEMENT FROM AN EXHAUST FAN, AS DESIGNED. ALL PNEUMATICS AND ELECTRONICS WERE CHECKED. ONE LOOSE CAPACITOR LYING NEAR THE BACK OF THE UNIT WAS FOUND UPON REMOVING THE COVER. BESIDES THAT, NO LOOSE CONNECTIONS ON ANY OF THE PNEUMATIC CIRCUITS WERE FOUND. THE UNIT WAS SENT TO (B)(4) FOR EVALUATION. THE UNIT WAS FOUND TO BE NOT EXCESSIVELY NOISY. THE LOOSE CAPACITOR AT THE BOTTOM OF THE UNIT WAS BROKEN OFF THE POWER MGMT. BOARD. REASON FOR LOOSE CAPACITOR COULD NOT BE DETERMINED. A CABLE TIE WAS ADDED TO THE CABLE TO PREVENT IT FROM HITTING THE PCBA. (B)(4).

    Description of Event or Problem · 1

    DURING A ROUTINE CHECK OF THE IABP, THE COMPANY REPRESENTATIVE OBSERVED THAT THE IABP GENERATED A LOUD HISSING NOISE AND A HIGH AMOUNT OF AIR COMING OUT OF VENT. NO PATIENT WAS INVOLVED. THE COMPANY REPRESENTATIVE TESTED THE IABP AND OBSERVED THAT THE IABP SOUND WAS ONLY PRESENT FOR A SHORT AMOUNT OF TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504663 CARDIOSAVE INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CARDIOSAVE

    Patients

    Seq Age Sex Outcome Treatment
    1