BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPUS LS-MANUAL

    MDR report key: 23099726 · Received September 19, 2025

    Report

    Report Number
    3003832357-2025-000683
    Event Type
    Injury
    Date Received
    September 19, 2025
    Date of Event
    September 17, 2025
    Report Date
    December 4, 2025
    Manufacturer
    REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
    Product Code
    LDD
    UDI-DI
    07613365002737
    PMA / PMN Number
    K200849
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATE EVENT DESCRIPTION DUE TO NEW INFORMATION RECEIVED VIA GOOD FAITH EFFORT. DEVICE IN TRANSIT, FINAL INVESTIGATION PENDING.

    Description of Event or Problem · 0

    THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS REMOTE SERVICE PERSONNEL AND WILL BE INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS LS-MANUAL INDICATING THAT DURING CRITICAL CARE TRANSPORT OF A CONFIRMED ACTIVE HEAD BLEED, THE PATIENT DECOMPENSATED RAPIDLY AND BECAME BRADYCARDIC. THE CRITICAL CARE TRANSPORT (CCT) TEAM RECOGNIZED THE PATIENT NEEDED TO BE PACED AND APPLIED THE THREE LEAD ELECTROCARDIOGRAM (EKG) CABLE FROM THE LS AND DEFIBRILLATION PADS. THE CCT TEAM REPORTED THAT A "CHECK DEFIB ELECTRODES" MESSAGE APPEARED WITHOUT A WAVEFORM. THE CREW REPLACED THE DEFIBRILLATION PADS IN AN ATTEMPT TO RECTIFY THE SITUATION; HOWEVER, THE SAME MESSAGE OCCURRED. THE CCT TEAM THEN POWERED THE DEVICE OF AND BACK ON IN A FURTHER ATTEMPT TO RESOLVE THE ISSUE. THE PATIENT WAS THEN IN A CARDIAC ARREST STATUS. THE CCT TEAM CONTINUED TO WORK THE PATIENT AS WELL AS TROUBLESHOOT THE DEVICE. A REQUEST FOR ADDITIONAL INFORMATION REGARDING THE INCIDENT AND PATIENT OUTCOME HAS BEEN SENT AND THE RESPONSE IS NOT YET RECEIVED.

    Description of Event or Problem · 0

    THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS REMOTE SERVICE PERSONNEL AND WILL BE INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS LS-MANUAL INDICATING THAT DURING CRITICAL CARE TRANSPORT OF A CONFIRMED ACTIVE HEAD BLEED, THE PATIENT DECOMPENSATED RAPIDLY AND BECAME BRADYCARDIC. THE CRITICAL CARE TRANSPORT (CCT) TEAM RECOGNIZED THE PATIENT NEEDED TO BE PACED AND APPLIED THE THREE LEAD ELECTROCARDIOGRAM (EKG) CABLE FROM THE LS AND DEFIBRILLATION PADS. THE CCT TEAM REPORTED THAT A "CHECK DEFIB ELECTRODES" MESSAGE APPEARED WITHOUT A WAVEFORM. THE CREW REPLACED THE DEFIBRILLATION PADS IN AN ATTEMPT TO RECTIFY THE SITUATION, HOWEVER THE SAME MESSAGE OCCURRED. THE CCT TEAM THEN POWERED THE DEVICE OF AND BACK ON IN A FURTHER ATTEMPT TO RESOLVE THE ISSUE. THE PATIENT WAS THEN IN A CARDIAC ARREST STATUS. THE CCT TEAM CONTINUED TO WORK THE PATIENT (CONTINUED MANUAL THERAPY, PHARMACEUTICAL SUPPORT AND CARDIAC MANAGEMENT WITHOUT DEFIBRILLATOR) AS WELL AS TROUBLESHOOT THE DEVICE. A TEMPUS PRO DEVICE WAS UTILIZED FOR RHYTHM RECOGNITION. RESPONSE RECEIVED TO GOOD FAITH EFFORT INDICATED BRADYCARDIA CONTINUED TO A RATE OF 40 BEATS PER MINUTE AND THE PACER FAILED. PATIENT PROCEEDED TO PULSELESS ELECTRICAL ACTIVITY (PEA) THEN RETURN OF SPONTANEOUS CIRCULATION (ROSC) (SINUS TACH) WITH PULSES. THE PATIENT WAS TRANSFERRED TO THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1759131 TEMPUS LS-MANUAL LOW ENERGY DEFIBRILLATOR LDD REMOTE DIAGNOSTIC TECHNOLOGIES LTD. 00-3020 07613365002737

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening