BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 2243861 · Received August 24, 2011

    Report

    Report Number
    1219856-2011-00304
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 23, 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
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED PER FIELD SERVICE REPORT SYMPTOM - PUMP STOPPED DURING TRANSPORT, NO ALARM, IN ELEVATOR, TAKEN OUT OF SERVICE. PREVENTATIVE MAINTENANCE (PM) DUE. FINDINGS/ACTION TAKEN: PUMP RAN 15 MIN ON DC (WITH FULL CHARGE), THEN DROPPED, NO ALARMS. REPLACED BATTERY AND FIBER OPTIC CONNECTOR. PERFORMED PM AND FUNCTIONAL CHECK - PASS. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2011 FROM THE FIELD SERVICE REPRESENTATIVE STATED THAT THE PT WAS RUSHED TO THE INTENSIVE CARE UNIT AND DURING TRANSPORT, THE PUMP STOPPED. AS A RESULT, THE PUMP WAS PLUGGED BACK IN AT THE HOSPITAL (ONE FLOOR APART, SHORT HALL AND STOPPED IN THE ELEVATOR) THE DELAY WAS ONE TO THREE MINUTES. NO MEDICAL/SURGICAL INTERVENTION WAS NEEDED. ALSO, IT IS UNDERSTOOD FROM THE FIELD SERVICE REPRESENTATIVE THAT THE PT OUTCOME WAS NO INJURY OR DEATH TO THE PT. AT SOME TIME THE PUMP WAS SWITCHED OUT AND SENT TO BIOMED WHERE IT WAS SERVICED. THE PUMP IS BACK IN SERVICE.

    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