BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERSONAL KINETIGRAPH (PKG) TABLET

    MDR report key: 17523752 · Received August 12, 2023

    Report

    Report Number
    MW5130700
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Date of Event
    September 22, 2021
    Report Date
    November 19, 2021
    Manufacturer
    GLOBAL KINETICS
    Product Code
    GYD
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THERE WAS A PROBLEM WITH THE PKG TABLET. IF YOU HAVE ANY QUESTIONS REGARDING THIS LETTER FOR MANUFACTURER NOTIFICATION, PLEASE DO NOT HESITATE TO CONTACT US. IT WAS NOTED THE APPLICATION WAS OPENED TO UPLOAD A WATCH THE APPLICATION WOULD NOT OPEN. IT WOULD ACT LIKE IT WOULD OPEN AND THEN GO BACK TO THE MAIN SCREEN. AFTER TRYING TO OPEN IT A FEW TIMES A SCREEN WOULD POP UP SAYING "PKG CLINIC KEEPS STOPPING." THE DEVICE WAS TURNED OFF SEVERAL TIMES AND RESTARTED BUT NOTHING WORKED. INFORMATION WAS UNABLE TO BE UPLOADED FROM THE WATCH AND IT WAS UNABLE TO PROGRAM OTHER WATCHES. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2193050 PERSONAL KINETIGRAPH (PKG) TABLET TRANSDUCER, TREMOR GYD GLOBAL KINETICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown