BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 1052556 · Received May 22, 2008

    Report

    Report Number
    1219856-2008-00247
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    February 5, 2008
    Report Date
    May 22, 2008
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: FIELD SVC EVALUATED THE CONSOLE AND REPLACED THE POWER SUPPLY. THE FUSES CHECKED GOOD. THE CONSOLE PASSED THE FUNCTIONAL AND ELECTRICAL SAFETY CHECKS. PUMP WAS RETURNED TO SVC ON 2/5/08.

    Description of Event or Problem · 1

    THE FIELD SVC REPORT INDICATES THAT THERE WAS NO AC POWER ON TRANSPORT. THE BATTERY CEASED WORKING AND ANOTHER PUMP HAD TO BE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOCAT2 WAVE INTRA-AORTIC BALLOON PUMP PRODUCTS DSP ARROW INTERNATIONAL INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK