BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTTOUCH

    MDR report key: 19123230 · Received April 17, 2024

    Report

    Report Number
    1000165971-2024-00326
    Event Type
    Malfunction
    Date Received
    April 17, 2024
    Date of Event
    March 21, 2024
    Report Date
    July 18, 2024
    Manufacturer
    MICROPORT CRM S.R.L.
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION LED TO THE FOLLOWING OBSERVATIONS: - THE POP-UPS AND/OR PROGRAMMING MENUS AND/OR DROPDOWN LIST ARE NOT VISIBLE BY THE USER. INDEED, THEY ARE PRESENT BUT DISPLAYED BEHIND THE MAIN SCREEN. THEREFORE, THE USER IS NOT ABLE TO CHOOSE/CLICK ON THE APPROPRIATE ANSWER/PARAMETER AND THIS EXPLAINS THE REPORTED FREEZE DURING THE PROGRAMMER SESSION. - THIS ISSUE HAS BEEN REPRODUCED BY THE R&D TEAM. - THE MOST LIKELY HYPOTHESIS IS A PROGRAMMER SOFTWARE ISSUE, AND IT WILL BE CORRECTED WITH THE NEXT SMARTVIEW VERSION. - THE COMPLAINT IS RECORDED FOR TRENDING PURPOSES.

    Description of Event or Problem · 0

    OA PARADYM RF DR WAS "INTERROGATED" WITH SV 3.16 IN THE PILOT CENTER (B)(6). AFTER THE MANUAL RV THRESHOLD TEST, IT WAS NO LONGER POSSIBLE TO SELECT THE RA THRESHOLD TEST OR ANY OTHER FUNCTION. THE APPLICATION FROZE AND I HAD TO REMOVE THE TABLET BATTERY. I RAN THE INTEGRATION AGAIN WITH ANOTHER TABLET RUNNING 3.14 AND ALL TESTS WORKED FINE.

    Description of Event or Problem · 0

    OA PARADYM RF DR WAS INTEROGATED WITH SV 3.16 IN THE PILOT CENTER AKH WIEN. AFTER THE MANUAL RV THRESHOLD TEST, IT WAS NO LONGER POSSIBLE TO SELECT THE RA THRESHOLD TEST OR ANY OTHER FUNCTION. THE APPLICATION FROZE AND I HAD TO REMOVE THE TABLET BATTERY. I RAN THE INTEGRATION AGAIN WITH ANOTHER TABLET RUNNING 3.14 AND ALL TESTS WORKED FINE.

    Description of Event or Problem · 0

    A PARADYM RF DR WAS INTEROGATED WITH SV 3.16 IN THE PILOT CENTER AKH WIEN. AFTER THE MANUAL RV THRESHOLD TEST, IT WAS NO LONGER POSSIBLE TO SELECT THE RA THRESHOLD TEST OR ANY OTHER FUNCTION. THE APPLICATION FROZE AND I HAD TO REMOVE THE TABLET BATTERY. I RAN THE INTEGRATION AGAIN WITH ANOTHER TABLET RUNNING 3.14 AND ALL TESTS WORKED FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1914592 SMARTTOUCH DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER MRM MICROPORT CRM S.R.L. SMARTTOUCH SOFTWARES MODULES
    2320080 SMARTTOUCH DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER MRM MICROPORT CRM S.R.L. SMARTTOUCH SOFTWARES MODULES

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown