BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 1002579 · Received February 8, 2008

    Report

    Report Number
    1219856-2008-00035
    Event Type
    Malfunction
    Date Received
    February 8, 2008
    Date of Event
    January 31, 2008
    Report Date
    February 8, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATH LAB PHONED THE HOTLINE AND STATED THE FOLLOWING: THE PUMP WAS EXCHANGED OFF THE PATIENT BECAUSE "HELIUM WAS LEAKING FROM THE TANK." THE REGISTERED NURSE STATED THAT THEY COULD SEE "BLUE HELIUM GAUGE GOING DOWN QUICKLY." THIS PUMP WAS SENT TO BIOMED.

    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