BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECONOLITH LITHOTRIPTOR (ESWL)

    MDR report key: 294875 · Received September 7, 2000

    Report

    Report Number
    294875
    Event Type
    Malfunction
    Date Received
    September 7, 2000
    Date of Event
    August 22, 2000
    Report Date
    August 30, 2000
    Manufacturer
    MEDISPEC LTD
    Product Code
    FED
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ESWL MACHINE (ULTRASOUND MACHINE USED FOR URINARY TRACT STONES) WOULD NOT WORK IN CONJUNCTION WITH EKG. PT'S CASE HAD TO BE CANCELLED AT THE LAST MINUTE BECAUSE THE BOX WOULD NOT "GATE" THE SHOCK WAVES THROUGH THE EKG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECONOLITH LITHOTRIPTOR (ESWL) ULTRASOUND "GATING BOX" FED MEDISPEC LTD * *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other