BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPUS PRO

    MDR report key: 12702840 · Received October 27, 2021

    Report

    Report Number
    3003832357-2021-10003
    Event Type
    Malfunction
    Date Received
    October 27, 2021
    Date of Event
    October 1, 2021
    Report Date
    July 23, 2025
    Manufacturer
    REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
    Product Code
    MHX
    UDI-DI
    05060472441027
    PMA / PMN Number
    K201746
    Removal / Correction Number
    Z-1997-2021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE INCIDENT WAS INITIATED ON (B)(6) 2021 AT 23:51, AND CONTINUED UNTIL (B)(6) 2021 AT 00:12. IT SHOULD BE NOTED THAT THE TEMPUS PRO IN THIS INCIDENT FAILED WHILE INTUBATING A PATIENT USING THE KARL STORZ VIDEO LARYNGOSCOPE. THE DEVICE SHUT DOWN AND RESTARTED ITSELF AFTER DISPLAYING A SCREEN WITH RED WRITING STATING THERE WAS A CRITICAL ERROR. THE PATIENT WAS IN CARDIAC ARREST WHEN THE SHUTDOWN OCCURRED. THE CREW WAS IN THE PROCESS OF OBTAINING AN AIRWAY USING THE VIDEO LARYNGOSCOPE FEATURE ON THE TEMPUS PRO. THE PATIENT DID EXPIRE THREE DAYS LATER. WHILE WE CANNOT SAY WITH ANY CERTAINTY THAT IT DID OR DID NOT CAUSE THE PATIENT¿S DETERIORATION, THE FAILURE OF THE DEVICE DID CAUSE A DELAY IN A CRITICAL PROCEDURE. FROM THE DEVICE EVALUATION THERE WAS NO FAULT FOUND. PHILIPS HAS CONFIRMED THAT THE THIS FAILURE COULD HAPPEN DUE TO A VERY RARE INTERMITTENT SOFTWARE ERROR, WHICH CAN OCCUR WHEN USING THE VIDEO LARYNGOSCOPE PHILIPS RDT IS DEVELOPING A SOFTWARE UPDATE TO RESOLVE THIS POTENTIAL ISSUE WHICH WILL BE PROVIDED VIA A DOWNLOADABLE LINK AND UPDATED IN THE FIELD AS SOON AS IT IS AVAILABLE. RECALL NUMBER Z-1997-2021

    Additional Manufacturer Narrative · 1

    A USER REPORT WAS RECEIVED RELATED TO A REPORTED PATIENT DEATH WHICH IS CURRENTLY BEING INVESTIGATED. AT THE TIME OF REPORTING, THE DEVICE HAS NOT YET BEEN RETURNED FOR INVESTIGATION. FURTHER UPDATES WILL BE PROVIDED WHEN THE DEVICE IS RECEIVED AND INVESTIGATION HAS PROGRESSED.

    Description of Event or Problem · 1

    THE INCIDENT DESCRIBED AS FOLLOWS BY THE CUSTOMER - THE INCIDENT WAS INITIATED ON (B)(6) 2021 AT 23:51, AND CONTINUED UNTIL (B)(6) 2021 AT 00:12. IT SHOULD BE NOTED THAT THE TEMPUS PRO IN THIS INCIDENT FAILED WHILE INTUBATING A PATIENT USING THE KARL STORZ VIDEO LARYNGOSCOPE. THE DEVICE SHUT DOWN AND RESTARTED ITSELF AFTER DISPLAYING A SCREEN WITH RED WRITING STATING THERE WAS A CRITICAL ERROR. THE PATIENT WAS IN CARDIAC ARREST WHEN THE SHUTDOWN OCCURRED. THE CREW WAS IN THE PROCESS OF OBTAINING AN AIRWAY USING THE VIDEO LARYNGOSCOPE FEATURE ON THE TEMPUS PRO. THE PATIENT DID EXPIRE THREE DAYS LATER. WHILE WE CANNOT SAY WITH ANY CERTAINTY THAT IT DID OR DID NOT CAUSE THE PATIENT¿S DETERIORATION, THE FAILURE OF THE DEVICE DID CAUSE A DELAY IN A CRITICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1601757 TEMPUS PRO MONITOR, PHYSIOLOGICAL, PATIENT (WITH ARRHTHMIA DETECTION OR AARMS) MHX REMOTE DIAGNOSTIC TECHNOLOGIES LTD. 00-1024-R 05060472441027

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death