BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEALTHTRONICS OSSATRON

    MDR report key: 2176693 · Received September 25, 2007

    Report

    Report Number
    1062240-2007-00001
    Event Type
    Malfunction
    Date Received
    September 25, 2007
    Date of Event
    August 29, 2007
    Report Date
    September 24, 2007
    Manufacturer
    SANUWAVE, INC.
    Product Code
    NBN
    PMA / PMN Number
    P990086
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MACHINE HAS BEEN TAKEN OUT OF SVC PENDING FULL EVAL UPON A VISIT OF A SVC ENGINEER TO THE SITE. INITIAL PHONE SCREEN INDICATES A SENSOR FAILURE. THIS REPORT IS SUBMITTED BECAUSE THE PT HAD ALREADY BEEN SEDATED. THE PROCEDURE FOR PAIN TREATMENT OF PLANTAR FASCIITIS HAD NOT BEGUN.

    Description of Event or Problem · 1

    DURING PRE-TEST START-UP, A HEAD COLLISION SENSOR WAS ACTIVATED AND COULD NOT BE DE-ACTIVATED BY THE DEVICE OPERATOR. THE ACTIVATION OF THIS SENSOR PREVENTED THE USE OF THE DEVICE. THE PT HAD ALREADY BEEN SEDATED IN PREPARATION FOR THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEALTHTRONICS OSSATRON HEALTHTRONICS OSSATRON NBN SANUWAVE, INC. OSA 120 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR