BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 2243885 · Received August 24, 2011

    Report

    Report Number
    1219856-2011-00300
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 15, 2011
    Report Date
    August 18, 2011
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED PER FIELD SERVICE REPORT SYMPTOM - UNIT SHUT OFF WHEN AC REMOVED WHEN ATTEMPTING TRANSPORT OF PT. FINDINGS/ACTION TAKEN: WAS UNABLE TO DUPLICATE UNIT SHUTTING OFF ON DC. ALL VOLTAGES CHECKED OK. REPLACED MISSING AC CORD CLIP. POSSIBLE THAT UNIT NOT FULLY CHARGED WHEN AC REMOVED. UNIT SHOWING 12.3 DC ON BATTERY UNIT. PASSED FUNCTIONAL CHECKOUT.

    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