BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACAT 1 IAB PUMP ASSEMBLY

    MDR report key: 1061107 · Received June 13, 2008

    Report

    Report Number
    1219856-2008-00291
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 28, 2008
    Report Date
    June 13, 2008
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    PMA / PMN Number
    K965209
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: FINDINGS/ACTION TAKEN: COULD NOT DUPLICATE PROBLEM. REPLACED POWER SUPPLY AND BATTERY. FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PERFUSIONIST PRESSED THE ARTERIAL PRESSURE ZERO KEY TO ZERO THE ART LINE DURING A TRANSPORT AND THE PUMP TURNED OFF AND THEN CAME BACK ON WITH THE DISTORTED DISPLAY. ANOTHER PUMP WAS PUT ON THE PATIENT AND THERE WERE NO REPORTED PATIENT COMPLICATIONS. PER FIELD SERVICE REPORT: SYMPTOM: DURING TRANSPORT PUMP SHUT OFF AND CAME BACK WITH DISTORTED DISPLAY WHEN ARTERIAL PRESSURE TRANSDUCER ZERO WAS PRESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACAT 1 IAB PUMP ASSEMBLY INTRA-AORTIC BALLOON PUMP PRODUCTS DSP ARROW INTERNATIONAL INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK