BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONICATOR PLUS 940

    MDR report key: 6311239 · Received February 8, 2017

    Report

    Report Number
    9614750-2017-00006
    Event Type
    Injury
    Date Received
    February 8, 2017
    Date of Event
    July 19, 2015
    Report Date
    February 8, 2015
    Manufacturer
    ITO CO., LTD. TSUKUBA FACTORY
    Product Code
    IMG
    PMA / PMN Number
    K071137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ITO EXAMINED THE DEVICE HISTORY RECORD FOR THE DEVICE INVOLVED IN THE ADVERSE EVENT. THERE WERE NO PROBLEMS OBSERVED DURING THE MANUFACTURING OR TESTING NOTED IN THE DHR. UPON RECEIPT OF THE SUBJECT DEVICE, ITO CONDUCTED A FAILURE ANALYSIS OF THE RETURNED DEVICE. ITO CONDUCTED THE FOLLOWING INSPECTIONS ON THE RETURNED DEVICE: APPEARANCE TEST: PASSED THE PRE-DEFINED CRITERIA. WITHSTAND VOLTAGE TEST: PASSED THE PRE-DEFINED CRITERIA. MEASUREMENT OF CURRENT LEAKAGE: 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 OUTPUT VOLTAGE WAVEFORM: WITHIN THE PRE-DEFINED SPECIFICATIONS. MEASUREMENT OF PROTECTIVE EARTH RESISTANCE: WITHIN THE PRE-DEFINED SPECIFICATIONS. ELECTROSTIMULATION SECTION SAFETY DEVICE TEST: PASSED THE PRE-DEFINED CRITERIA. MEASUREMENT OF ULTRASOUND OUTPUT: WITHIN THE PRE-DEFINED SPECIFICATIONS. ULTRASOUND SECTION SAFETY DEVICE TEST: PASSED THE PRE-DEFINED CRITERIA. AUTO CONTACT FUNCTION TEST: PASSED THE PRE-DEFINED CRITERIA. BUZZER FUNCTION TEST: PASSED THE PRE-DEFINED CRITERIA. FAN MOTOR FUNCTION TEST: PASSED THE PRE-DEFINED CRITERIA. IMPACT TEST: PASSED THE PRE-DEFINED CRITERIA. ITO SAVED ALL THE DATA IN THE INVESTIGATION FILE ON THE SUBJECT DEVICE (S/N: (B)(4)). CONCLUSION REACHED BASED ON THE INVESTIGATION AND ANALYSIS RESULT: THE SUBJECT DEVICE FUNCTIONS WITHOUT ANY ABNORMALITY. ITO REMINDED THE USER OF THE CORRECT USAGE, AS DESCRIBED IN THE USER MANUAL. THE USER FACILITY DID NOT DISCLOSE THE PATIENT'S IDENTIFIER.

    Description of Event or Problem · 1

    ON (B)(6) 2015, DURING AN ARTHROSCOPIC DECOMPRESSION PROCEDURE CONDUCTED BY A PHYSIOTHERAPIST, THE SUBJECT DEVICE BURNED A POINT ON THE PATIENT'S RIGHT SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94571 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 66 YR Other