BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 2113872 · Received May 18, 2011

    Report

    Report Number
    1219856-2011-00171
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 18, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED PER FIELD SERVICE REPORT: PUMP WAS ON PT. SYMPTOM - BALLOON RUPTURED. DID NOT ALARM WITH HELIUM LOSS. DISPLAY IS INTERMITTENT WITH BLACK AREA STRIP DOWN MIDDLE OF DISPLAY. FINDINGS/ACTIONS TAKEN: PERFORMED FUNCTIONAL CHECK OF PUMP. HELIUM ALARMS ARE WORKING NORMALLY. REPLACED SUSPECT DISPLAY HEAD AND CABLE (DID NOT SEE THE DISPLAY PROBLEM).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK