BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 1376206 · Received February 27, 2009

    Report

    Report Number
    1219856-2009-00100
    Event Type
    Malfunction
    Date Received
    February 27, 2009
    Date of Event
    February 18, 2009
    Report Date
    February 27, 2009
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    FINDINGS/ACTION TAKEN: PROBLEM CONFIRMED. REPLACED POWER SUPPLY. PERFORMED FUNCTIONAL CHECK LIST - PASS. PERFORMED ELECTRICAL SAFETY TEST- PASS. FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED PER FIELD SERVICE REPORT: PATIENT INVOLVEMENT "YES." SYMPTOM: WITH A/C CORD PLUGGED IN, STILL RUNNING ON D/C POWER. NO GREEN LIGHT.

    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