BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 748957 · Received July 26, 2005

    Report

    Report Number
    MW1036093
    Event Type
    Malfunction
    Date Received
    July 26, 2005
    Date of Event
    June 29, 2005
    Report Date
    June 30, 2005
    Manufacturer
    AIR GAS: DISTRIBUTOR VNG
    Product Code
    ECX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HELIUM HIGH PURITY 4.8 GRADE 6,000 PSI TANK USED ON SEEDNET MACHINE FOR CRYOABLATION. DURING NEEDLE TEST PHASE, HELIUM IS SENT TO NEEDLES TO CHECK INTEGRITY, ICE FORMATION NOTED ON TIPS OF NEEDLES. DURING LAST 50 SECS OF TEST PHASE, HELIUM IS SENT TO TIPS OF NEEDLES TO THAW ICE FORMATION BUT, THIS DID NOT OCCUR. THE ICE FORMATION CONTINUED TO OCCUR ON NEEDLE TIPS. HELIUM TANK REMOVED FROM MACHINE AND ISOLATED. NO PATIENT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * HELIUM HIGH PUIRTY 4.8 GRADE ECX AIR GAS: DISTRIBUTOR VNG UN1046 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *