BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 1040758 · Received May 9, 2008

    Report

    Report Number
    1219856-2008-00227
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    April 19, 2008
    Report Date
    May 9, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PER FIELD SERVICE REPORT, THE TECHNICIAN COULD NOT DUPLICATE THE EVENT. THE SENIOR MANAGER GLOBAL MARKETING AND PRODUCT MANAGER AS WELL AS THE GLOBAL CLINICAL SUPPORT SPECIALIST "ARE WORKING WITH ACCOUNT WITH TEST EQUIPMENT TO EVALUATE INTERFERENCE AND DROPPED SIGNAL FROM MONITOR." THE CUSTOMER WAS ASKED TO "DIRECT CONNECT ECG AND REFRAIN FROM SLAVING TO AVOID MONITOR INTERRUPTION."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MANAGER OF CARDIAC PROCEDURES PHONED THE SALES REP AND STATED THE FOLLOWING: "OVER THE WEEKEND, THEY LOST THE ECG TRIGGER" AND SUBSEQUENTLY "HAD TROUBLE RE-ESTABLISHING." "THE PUMP WAS STILL ON THE PT AND WILL BE SWAPPED OUT TODAY." 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