BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPUS LS-MANUAL

    MDR report key: 15716807 · Received November 2, 2022

    Report

    Report Number
    3003832357-2022-00034
    Event Type
    Injury
    Date Received
    November 2, 2022
    Date of Event
    October 3, 2022
    Manufacturer
    SCHILLER AG
    Product Code
    LDD
    UDI-DI
    07613365002737
    PMA / PMN Number
    K200849
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    AS DESCRIBED BY ASSISTANT CHIEF STATES THE EMT'S ATTEMPTED TO UTILIZE THE DEVICE FOR DEMAND PACING OF PATIENT WHO WAS BRADYCARDIC/PERI-ARREST. PACER FAILED AND PRESENTED WITH "HARDWARE FAILURE" ERROR MESSAGE ON SCREEN. DEVICE TURNED OFF AND BACK ON AND ISSUE PERSISTED. PADS ALSO KEPT READING AS "CHECK ELECTRODES" EVEN THOUGH THEY PROPERLY ADHERED TO THE PATIENT'S SKIN. A USER REPORT WAS RECEIVED RELATED TO A REPORTED PRODUCT PROBLEM 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 · 0

    AS DESCRIBED BY ASSISTANT CHIEF STATES THE EMT'S ATTEMPTED TO UTILIZE THE DEVICE FOR DEMAND PACING OF PATIENT WHO WAS BRADYCARDIC/PERI-ARREST. PACER FAILED AND PRESENTED WITH "HARDWARE FAILURE" ERROR MESSAGE ON SCREEN. DEVICE TURNED OFF AND BACK ON AND ISSUE PERSISTED. PADS ALSO KEPT READING AS "CHECK ELECTRODES" EVEN THOUGH THEY PROPERLY ADHERED TO THE PATIENT'S SKIN. A USER REPORT WAS RECEIVED RELATED TO A REPORTED PRODUCT PROBLEM WHICH WAS INVESTIGATED BY SCHILLER (MANUFACTURER). THE LOGFILES PROVIDED BY THE CUSTOMER WERE INVESTIGATED AT SCHILLER AG AND THE INVESTIGATION ON THE LOGFILE SHOWED THE OCCURRENCE OF SEVERAL "ERROR 26" - DPM HARDWARE FAILURE. THIS ISSUE APPEARS TO BE A NON-REPRODUCIBLE PACER ERROR, WHICH IS LOGGED AS ERROR 26 IN THE LOGFILE. AS THE ERROR IS NOT REPRODUCIBLE, THE ROOT CAUSE CANT BE CONCLUDED. HOWEVER, IT IS SUSPECTED THAT THE ERROR IS CAUSED DUE TO COMMUNICATION ISSUE TO THE DPM BOARD. THIS ERROR IS UNDER OBSERVATION IN SAGQI-137 (CAPA-0029) - TEMPUS LS: PACER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2688500 TEMPUS LS-MANUAL LOW ENERGY DEBFIBRILLATOR LDD SCHILLER AG 00-3020 07613365002737

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other