BEUDAMED
    FDA Adverse Event Death Summary report: N

    TEMPUS LS - MANUAL

    MDR report key: 12924724 · Received December 3, 2021

    Report

    Report Number
    3003832357-2021-10006
    Event Type
    Death
    Date Received
    December 3, 2021
    Date of Event
    November 4, 2021
    Manufacturer
    SCHILLER AG
    Product Code
    LDD
    UDI-DI
    07613365002737
    PMA / PMN Number
    K200849
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    THE INCIDENT DESCRIBED AS FOLLOWS BY THE CUSTOMER - PATIENT WAS 2 YEARS OLD MALE (DOB:(B)(6) ) ASYSTOLE ON ARRIVAL. ADULT PADS WERE USED AND WOULD WORK FOR 25-30 SEC AND THEN ECG TRACING WOULD DISAPPEAR, AND WORK FOR 25-30 SEC. ¿CHANGED PADS AND THEY WORKED FINE REST OF CALL¿ PATIENT PRONOUNCED DEAD AT HOSPITAL.

    Description of Event or Problem · 0

    THE INCIDENT DESCRIBED AS FOLLOWS BY THE CUSTOMER - PATIENT WAS 2 YEARS OLD MALE (DOB: (B)(6) 2018) ASYSTOLE ON ARRIVAL. ADULT PADS WERE USED AND WOULD WORK FOR 25-30 SEC AND THEN ECG TRACING WOULD DISAPPEAR, AND WORK FOR 25-30 SEC. ¿CHANGED PADS AND THEY WORKED FINE REST OF CALL¿ PATIENT PRONOUNCED DEAD AT THE HOSPITAL. THE DEVICE ARRIVED AT THE MANUFACTURER SCHILLER ON 05 JULY 2022. NO DEVICE FAILURE WAS DETECTED DURING THE ENTRY TEST. THE DEVICE PASSED ALL TESTS SUCCESSFULLY. NO FAILURE COULD BE FOUND. ON EVALUATION OF THE DEVICE IT IS FOUND THAT DEFIBRILLATOR PADS WERE CONNECTED TO THE TEMPUS LS MANUAL. THE DEFIBRILLATOR PADS WERE THEN PLACED ON A PERSON. THE DEVICE WAS STARTED AND AN ECG SIGNAL WAS VISIBLE. IT WAS NOT POSSIBLE TO REPRODUCE THE DESCRIBED ISSUE. BASED ON THE DEVICE TESTING AND INVESTIGATION PERFORMED ON THE DEVICE AT SAG, NO DEVICE MALFUNCTION COULD BE FOUND. AS IT CAN BE PROVED THAT THE DEVICE DOES NOT MALFUNCTION, THE DEVICE WORKED AS INTENDED DURING THE INTERVENTION AND THE DISCONNECTS EITHER BY THE ACCESSORIES (DEFI BADS) OR DUE TO PATIENT'S CONDITION. THEREFORE THIS CASE IS CONSIDERED AS NOT REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1826173 TEMPUS LS - MANUAL LOW ENERGY DEFIBRILLATOR LDD SCHILLER AG 00-3020 07613365002737

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Male Death