BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 1571346 · Received December 8, 2009

    Report

    Report Number
    1219856-2009-00557
    Event Type
    Malfunction
    Date Received
    December 8, 2009
    Date of Event
    November 16, 2009
    Report Date
    December 7, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED PER FIELD SERVICE REPORT: SYMPTOM - INTRA-AORTIC BALLOON PUMP (IABP) DID NOT READ THE LAST TWO FIBEROPTIX SENSOR (FOS) CATHETERS. NO TONES OR CHANGE OF FOS LIGHT ON DISPLAY. FINDINGS/ACTIONS/TAKEN: FOS CONNECTORS APPEAR TO HAVE BLOOD ON SLIDE AND DOOR. REPLACED FOS SLIDER AND STILL WOULD NOT READ THREE DIFFERENT FOS TESTERS. REPLACED THE FOS PNEUMATIC CONTROL SWITCH. READS CATHETER AND CAL KEY. PASSED FUNCTIONAL CHECKOUT AND RETURNED TO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOCAT2 WAVE INTRA-AORTIC BALLOON PUMP PRODUCTS DSP ARROW INTL., INC. KC8111878

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK