BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 2052034 · Received March 2, 2011

    Report

    Report Number
    1219856-2011-00085
    Event Type
    Malfunction
    Date Received
    March 2, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 24, 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
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED PER FIELD SERVICE REPORT: SYMPTOM - DURING TRANSPORT PUMP RAN 15 MINUTES BEFORE SHUTTING OFF. FINDINGS/ACTION TAKEN: FOUND BATTERY OPERATION LESS THAN 10 MINUTES; SHUT OFF WITH NO ALARMS. REPLACED BATTERY. FUNCTIONAL CHECK OK. PER THE PERFUSIONIST, THE PUMP WAS EXCHANGED OFF THE PT. THE TRANSPORT WAS WITHIN THE HOSPITAL AND THE DELAY IN THERAPY WAS APPROX 5 MINUTES. THERE WERE NO REPORTED PT COMPLICATIONS.

    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