BEUDAMED
    FDA Adverse Event Death Summary report: N

    TEMPUS LS - MANUAL

    MDR report key: 12917335 · Received December 2, 2021

    Report

    Report Number
    3003832357-2021-10004
    Event Type
    Death
    Date Received
    December 2, 2021
    Date of Event
    October 11, 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 (B)(6) OLD MALE (DOB: (B)(6)) WITH POSSIBLE COMPLAINTS OF SIDS (SUDDEN INFANT DEATH SYNDROME). PEDI PADS WERE PLACED ON THE PATIENT. PATIENT WAS IN ASYSTOLE. ¿MID ARREST LOST ECG SIGNAL UNPLUGGED AND PLUG IN PADS FOR 25-30 SEC AND THEN STARTED WORKING¿ PATIENT TRANSPORTED TO HOSPITAL WHERE HE WAS PRONOUNCED DEAD.

    Description of Event or Problem · 0

    THE INCIDENT DESCRIBED AS FOLLOWS BY THE CUSTOMER - PATIENT WAS 2 MONTHS OLD MALE (DOB: (B)(6) 2021) WITH POSSIBLE COMPLAINTS OF SIDS (SUDDEN INFANT DEATH SYNDROME). PEDI PADS WERE PLACED ON THE PATIENT. PATIENT WAS IN ASYSTOLE. ¿MID ARREST LOST ECG SIGNAL UNPLUGGED AND PLUG IN PADS FOR 25-30 SEC AND THEN STARTED WORKING¿ PATIENT TRANSPORTED TO HOSPITAL WHERE HE WAS PRONOUNCED DEAD. THE DEVICE INVESTIGATED BY THE MANUFACTURER SCHILLER. NO DEVICE FAILURE WAS DETECTED DURING THE ENTRY TEST. THE DEVICE PASSED ALL TESTS SUCCESSFULLY. BASED ON THE RESCUE FILES, IT CAN BE SHOWN THAT AT NO TIME OF THE INTERVENTION ANY ECG SIGNAL WAS RECORDED. AS THE CUSTOMER CLAIMS THAT AN "ECG SIGNAL" WAS RECORDED BUT DISAPPEARED INTERMITTENTLY, THE CUSTOMER MUST HAVE MEANT THE DEFI SIGNAL RECORDED VIA THE DEFIB PADS. THE RECORDINGS OF THE DEFI SIGNAL SHOWS SEVERAL DISCONNECTIONS (THE FIRST DISCONNECTION OF THE SIGNAL WAS RECORDED AFTER CA. 25 MINUTES OF CPR ON THE PATIENT WHICH WAS ALREADY IN ASYSTOLE UP ON ARRIVAL). SEVERAL DISCONNECTIONS WERE RECORDED AFTER 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, DESPITE ALL THE EFFORT. THEREFORE, IT CAN BE CONCLUDED, THAT THE DEVICE WORKED AS INTENDED ACCORDING TO IT'S SPECIFICATION AND ANY INCOMPATIBILITY BETWEEN THE TEMPUS LS MANUAL AND THE DEFIBRILLATOR PADS CAN BE EXCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1817255 TEMPUS LS - MANUAL LOW ENERGY DEFIBRILLATOR LDD SCHILLER AG 00-3020 07613365002737

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Male Death