BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPUS LS - MANUAL

    MDR report key: 14497787 · Received May 25, 2022

    Report

    Report Number
    3003832357-2022-00005
    Event Type
    Malfunction
    Date Received
    May 25, 2022
    Date of Event
    February 7, 2022
    Manufacturer
    SCHILLER AG
    Product Code
    LDD
    UDI-DI
    07613365002737
    PMA / PMN Number
    K200849
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    AS CUSTOMER DESCRIBED - CREWS RESPONDED FOR A PATIENT, DURING THE CARE CYCLE PACING WAS INDICATED, PACING WAS THEN ATTEMPTED WITH THE DEVICE STOPPING AND INITIATING A ¿DPM HARDWARE FAILURE¿ MESSAGE. A SECOND APPARATUS WAS CALLED AND A SECOND LS WAS USED TO PACE THE PATIENT TO THE HOSPITAL. PATIENT CARE WAS TRANSFERRED TO THE HOSPITAL, THE PATIENT WAS ALIVE AND BEING TREATED BY HOSPITAL STAFF. SOME TIME AFTER THE HOSPITAL INITIATED PATIENT TRANSFER TO A MORE ADVANCED HOSPITAL, THE CUSTOMER WAS DISPATCHED FOR THIS TRANSPORT. DURING THE SECOND ENCOUNTER WITH THIS PATIENT, A SECOND LS FAILED TO PACE WITH ¿ DPM HARDWARE FAILURE¿, ANOTHER APPARATUS WAS CALLED TO PROVIDE PACING DURING TRANSPORTATION TO THE ADVANCED HOSPITAL. THE LOG FILES OF THE DEVICE WERE ANALYSED BY SCHILLER (MANUFACTURER). AS PER THAT THE PACER STARTED SEVERAL TIMES BUT ALWAYS STOPPED. THE "HARDWARE FAILURE (DPM)¿ WAS DISPLAYED TO THE USER. THIS EVENT SEEMS TO BE A KNOWN ISSUE "PACER ERROR 26" WHICH IS NON-REPRODUCIBLE AND IS UNDER TRENDING AND INTERNAL INVESTIGATION WITH THE DEDICATED (B)(4) (CAPA-(B)(4)) - TEMPUS LS: PACER ISSUES.

    Description of Event or Problem · 0

    AS CUSTOMER DESCRIBED - CREWS RESPONDED FOR A PATIENT, DURING THE CARE CYCLE PACING WAS INDICATED, PACING WAS THEN ATTEMPTED WITH THE DEVICE STOPPING AND INITIATING A ¿DPM HARDWARE FAILURE¿ MESSAGE. A SECOND APPARATUS WAS CALLED AND A SECOND LS WAS USED TO PACE THE PATIENT TO THE HOSPITAL. PATIENT CARE WAS TRANSFERRED TO THE HOSPITAL, THE PATIENT WAS ALIVE AND BEING TREATED BY HOSPITAL STAFF. SOME TIME AFTER THE HOSPITAL INITIATED PATIENT TRANSFER TO A MORE ADVANCED HOSPITAL, THE CUSTOMER WAS DISPATCHED FOR THIS TRANSPORT. DURING THE SECOND ENCOUNTER WITH THIS PATIENT, A SECOND LS FAILED TO PACE WITH ¿ DPM HARDWARE FAILURE¿, ANOTHER APPARATUS WAS CALLED TO PROVIDE PACING DURING TRANSPORTATION TO THE ADVANCED HOSPITAL. THE LOG FILES OF THE DEVICE WERE ANALYSED BY SCHILLER (MANUFACTURER). AS PER THAT THE PACER STARTED SEVERAL TIMES BUT ALWAYS STOPPED. THE "HARDWARE FAILURE (DPM)¿ WAS DISPLAYED TO THE USER. THIS EVENT SEEMS TO BE A KNOWN ISSUE "PACER ERROR 26" WHICH IS NON-REPRODUCIBLE AND IS UNDER TRENDING AND INTERNAL INVESTIGATION WITH THE DEDICATED SAGQI-137 (CAPA-0029) - TEMPUS LS: PACER ISSUES. THE DEVICE HAS BEEN INVESTIGATED BY THE MANUFACTURER SCHILLER AND NO PROBLEM WAS FOUND WITH THE DEVICE. A REPORT FROM THE MANUFACTURER HAS BEEN ATTACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1976274 TEMPUS LS - MANUAL LOW ENERGY DEFIBTRLLATOR LDD SCHILLER AG 00-3020 07613365002737

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other