BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPID² THERAPY SYSTEM

    MDR report key: 10799840 · Received November 6, 2020

    Report

    Report Number
    8021774-2020-00008
    Event Type
    Malfunction
    Date Received
    November 6, 2020
    Date of Event
    October 22, 2020
    Report Date
    October 19, 2021
    Manufacturer
    THE MAGSTIM COMPANY LIMITED
    Product Code
    OBP
    PMA / PMN Number
    K162935
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING PRESENTED TO YOU TO ERR ON THE SIDE OF CAUTION AS THE PERCEPTION OF 'SENSE OF SHOCKING AND ELECTRICITY' IS AN INDIVIDUAL/PERSONAL OBSERVATION. WITHOUT THE INVESTIGATION CURRENTLY COMPLETED, IT CANNOT BE SAID WHETHER THIS OBSERVATION MIGHT/MIGHT NOT LEAD TO SERIOUS INJURY. THERE WAS AN INSPECTION OF THE DEVICE TAKEN AND THERE WAS SLIGHT SURFACE DAMAGE ON THE SIDE OF THE COIL BUT NO CRACKS OR ANY STRUCTURAL DAMAGE. THE SAFETY TESTS UNDERTAKEN WERE - DIELECTRIC STRENGTH - 13.1KV COIL ASSEMBLY (PASS)- 13.1 KV COIL ADAPTOR ASSEMBLY (PASS)- 3KV BETWEEN HV & LV (PASS) INDUCTANCE - 13.1 H (PASS). AFTER THE MAGSTIM ENGINEER ESTABLISHED THAT THE COIL WAS SAFE, THE COIL WAS FIRED WITH THE SYSTEM AND WORKED CORRECTLY. THE COIL HAS THE CORRECT MAGNETIC PEAK FIELD READING (INITIAL FINDING, FURTHER TESTING TO CONFIRM). THEY ALSO COMPARED MAGNETIC PULSE FEEL BETWEEN AN ASSET COIL AND THERE WAS NO NOTICEABLE DIFFERENCE. THEN THEY OPENED THE COIL TO INSPECT INTERNALLY, AND THE COIL HAS BEEN BUILT CORRECTLY. THE DUMB TRAY IS MADE FROM THE PREVIOUS REVISION MATERIAL AND THERE WERE SOME FAINT MICRO-FRACTURING IN THE PLASTIC TRAY. THE COIL HEAD WAS THEN TESTED AT 13.1KV WITHOUT THE CASES AND PASSED. FROM TESTING OF THE COIL SEPARATE AND AS PART OF THE ORIGINAL RAPID² THERAPY SYSTEM THERE WERE NO SIGNS OF ANY POSSIBLE CAUSE FOR THE SHOCKING OF A PATIENT OR THAT THEY HAD ANY CONTACT WITH VOLTAGE FROM THE DEVICE.

    Description of Event or Problem · 0

    THE COMPLAINT RECEIVED (FROM THE UNITED STATES) WAS REGARDING A PATIENTS AND OPERATORS REPORTED 'SHOCKING', PAIN AND TINGLING LIKE ELECTRICITY. NO SERIOUS HARM WAS REPORTED.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING PRESENTED TO YOU TO ERR ON THE SIDE OF CAUTION AS THE PERCEPTION OF 'SENSE OF SHOCKING AND ELECTRICITY' IS AN INDIVIDUAL/PERSONAL OBSERVATION. WITHOUT THE INVESTIGATION CURRENTLY COMPLETED, IT CANNOT BE SAID WHETHER THIS OBSERVATION MIGHT/MIGHT NOT LEAD TO SERIOUS INJURY. THE DEVICE HAS BEEN REQUESTED TO BE RETURNED FROM THE CUSTOMER TO MAGSTIM FOR INVESTIGATION. THE MAGSTIM COMPANY LTD. IS, AS PER YOUR REQUEST, CURRENTLY IN THE PROCESS OF SETTING UP A WEBTRADER ACCOUNT FOR MAGSTIM INC. USA. DURING THIS TRANSITION TIME, PLEASE ACCEPT THIS SUBMISSION AS OF THE MAGSTIM COMPANY LTD. AND MAGSTIM INC. USA BOTH. EXEMPTION NUMBER E2018009. THE MAGSTIM COMPANY LIMITED (REGISTRATION NUMBER CFN 8021774) IS SUBMITTING THIS REPORT ON BEHALF OF MAGSTIM INC. (REGISTRATION NUMBER FEI (B)(4)).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM DISPLAYED ERRORS (E70 AND E71). IN ADDITION TO THIS, PATIENTS AND OPERATORS REPORTED 'SHOCKING', PAIN AND TINGLING LIKE ELECTRICITY. NO SERIOUS HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262863 RAPID² THERAPY SYSTEM RAPID² THERAPY SYSTEM OBP THE MAGSTIM COMPANY LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other