BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPUS PRO

    MDR report key: 15318874 · Received August 30, 2022

    Report

    Report Number
    3003832357-2022-00021
    Event Type
    Malfunction
    Date Received
    August 30, 2022
    Date of Event
    July 29, 2022
    Manufacturer
    REMOTE DIAGNOSTIC TECHNOLOGIES (RDT)
    Product Code
    MHX
    UDI-DI
    05060472441027
    PMA / PMN Number
    K201746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    AS PER CUSTOMER ' TEMPUS PRO - SHUT DOWN WHILE IN PATIENT USE, POWERED BACK UP AND PERFORMED SELF TEST. LOG FILES UNDER REVIEW FOR THE EVALUATION.

    Description of Event or Problem · 0

    CUSTOMER REPORTED ' TEMPUS PRO - SHUT DOWN WHILE IN PATIENT USE, POWERED BACK UP AND PERFORMED SELF TEST. UPON RECEIPT OF THE DEVICE LOGS THE RDT PERFORMED AN IN DEPTH ANALYSIS WITH THE SUPPORT OF MINDTECK. AND CONFIRMED THERE WAS NO SOFTWARE ISSUES COULD BE IDENTIFIED THAT ATTRIBUTED TO THE TEMPUS RESTART. ON THE DAY OF THE REPORTED INCIDENT, THE TEMPUS PRO WAS RUNNING FROM THE BATTERY AND NOT CONNECTED TO MAINS. IN BETWEEN CYCLES, THE BATTERY WAS EITHER CHARGED OR SWAPPED OUT FROM THE DEVICE. SWAPPING BETWEEN BATTERIES COULD HAVE LED TO INCORRECT FITTING OF THE BATTERY WHICH MAY HAVE CAUSED THE LOSS OF POWER. THE DEVICE WAS RETURNED FOR INVESTIGATION AND POWER CYCLED THE TEMPUS 100 TIMES AND TESTED WITH MEDICAL PARAMETERS FOR 2 WEEKS. THE DEVICE FUNCTIONS ARE WORKING CORRECTLY AND NO DEFECTS WERE FOUND. NO FAULT COULD BE IDENTIFIED FOR THE CAUSE OF THE RESET. THE MOST LIKELY CAUSE WOULD HAVE BEEN AN INCORRECT BATTERY FITTING TO THE DEVICE. THE TEMPUS PRO IS PERFORMING TO SPECIFICATION AND IS TO BE RETURNED TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134254 TEMPUS PRO MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) MHX REMOTE DIAGNOSTIC TECHNOLOGIES (RDT) 00-1024-R 05060472441027

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other