BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONICATOR PLUS 940

    MDR report key: 6462422 · Received April 5, 2017

    Report

    Report Number
    9614750-2017-00008
    Event Type
    Injury
    Date Received
    April 5, 2017
    Date of Event
    January 11, 2017
    Report Date
    April 25, 2015
    Manufacturer
    ITO CO., LTD. TSUKUBA FACTORY
    Product Code
    IMG
    PMA / PMN Number
    K071137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF THE DEVICE INVOLVED IN THE ADVERSE EVENT, ITO CONDUCTED A FAILURE ANALYSIS OF THE RETURNED DEVICE. INSPECTION OF THE MAIN UNIT RETURNED: HIGH VOLTAGE TEST: PASSED. MEASUREMENT OF LEAKAGE CURRENT: WITHIN THE PRE-DEFINED SPECIFICATIONS. MEASUREMENT OF POWER INPUT: WITHIN THE PRE-DEFINED SPECIFICATIONS. MEASUREMENT OF OUTPUT VOLTAGE: WITHIN THE PRE-DEFINED SPECIFICATIONS. MEASUREMENT OF OUTPUT CURRENT: WITHIN THE PRE-DEFINED SPECIFICATIONS. MEASUREMENT OF FREQUENCE: WITHIN THE PRE-DEFINED SPECIFICATIONS. MEASUREMENT OF PROTECTIONAL GROUND RESISTANCE: WITHIN THE PRE-DEFINED SPECIFICATIONS. TEST ON SAFETY MECHANISM: PASSED. TEST ON OVER-CURRENT DETECTION FUNCTION: PASSED. MEASUREMENT OF ULTRASOUND OUTPUT: WITHIN THE PRE-DEFINED SPECIFICATIONS. TEST ON LED LAMP: PASSED. TEST ON FAN MOTOR: PASSED. TEST ON BUZZER: PASSED. TEST ON UNIT DISPLAY: PASSED. INSPECTION OF CONSUMABLE ACCESSORIES RETURNED: INSPECTION ON VISCOSITY OF THE ELECTRODE SURFACE: DETERIORATION OBSERVED. CONCLUSION: ITO CONCLUDED BASED ON THE ANALYSIS THAT THE ELECTRODES WITH DETERIORATED SURFACE MAY HAVE RESULTED IN THE CONCENTRATION OF ELECTRIC CURRENT, WHICH CAUSED THE PATIENT'S BURN. IN ORDER TO PREVENT THE RECURRENCE, ITO REMINDED THE USER TO FOLLOW THE INSTRUCTION FOR USE CONTAINED IN THE USER MANUAL INCLUDING THE REPLACEMENT OF ELECTRODES BEFORE DETERIORATION OF THE SURFACE.

    Description of Event or Problem · 1

    THE PATIENT WAS TREATED WITH THE SUBJECT DEVICE WITH QUADRUPOLE INTERFERENCE WAVE AT 70MA OUTPUT FOR FIFTEEN MINUTES. THE PATIENT NOTICED A BLISTER ON THE UPPER ABDOMINAL AREA AFTER THE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243804 SONICATOR PLUS 940 STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT IMG ITO CO., LTD. TSUKUBA FACTORY ME940

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other