BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACAT 1 IAB PUMP ASSEMBLY JAPANESE

    MDR report key: 1061122 · Received June 13, 2008

    Report

    Report Number
    1219856-2008-00267
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    July 27, 2007
    Report Date
    June 13, 2008
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    PMA / PMN Number
    K965209
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: ACTIONS TAKEN: CABLE BRACKET ATTACHED, SCREW CHANGED, HOT BONDED, CHANGED THE BATTERY LOAD CABLE AND BRACKET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "DURING DRIVING, SUDDENLY, FOUR FIFTHS OF THE SCREEN FROM THE LEFT SIDE BECAME DARK AND ONLY THE AREA DESCRIBING THE HELIUM GAS REMAINING WAS DISPLAYED; IT WAS "0". AS A RESULT, "THE PUMP WAS SWITCHED OFF AND THEN SWITCHED BACK ON AGAIN AT THIS TIME, IT WORKED NORMALLY AGAIN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACAT 1 IAB PUMP ASSEMBLY JAPANESE INTRA-AORTIC BALLOON PUMP PRODUCTS DSP ARROW INTERNATIONAL INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK