BEUDAMED
    FDA Adverse Event Death Summary report: N

    TEMPUS LS - MANUAL

    MDR report key: 13453971 · Received February 4, 2022

    Report

    Report Number
    3003832357-2022-00001
    Event Type
    Death
    Date Received
    February 4, 2022
    Date of Event
    December 30, 2021
    Manufacturer
    SCHILLER AG
    Product Code
    LDD
    UDI-DI
    07613365002737
    PMA / PMN Number
    K200849
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : LOG FILES INVESTIGATION PERFORMED.

    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 COMPLAINT AS DESCRIBED BY THE CUSTOMER "THE CREW ENCOUNTERED A PERSON IN CARDIAC ARREST AND HAD DIFFICULTY GETTING THE DEFIBRILLATION ELECTRODES TO READ A RHYTHM. THE INITIAL PADS DISPLAYED A DASHED LINE AND THE MESSAGE ¿CHECK ELECTRODES¿. THE CREW REMOVED THE PADS, WHICH WERE REPORTED TO BE WELL ADHERED, AND RE-PREPARED THE SKIN. THE CREW THEN REPLACED THE PADS WITH A NEW SET. THE SECOND SET OF PADS ALSO DISPLAYED THE ¿CHECK ELECTRODES¿ MESSAGE AND A DASHED LINE. THE CREW THEN PLACED THE 3 LEAD MONITORING ELECTRODES TO CHECK THE PATIENT¿S RHYTHM AND FOUND THE PATIENT TO BE IN ASYSTOLE. TEMPUS PADS LOT Y010521-04 IT SHOULD BE NOTED THAT THE PADS WERE DISCONNECTED FROM THE INITIAL LS AND ATTACHED TO ANOTHER LS THAT WAS ON SCENE (7022.00925) AND THEY GAVE THE SAME ERROR MESSAGE. BOTH TEMPUS LS DEVICES HAVE SUBSEQUENTLY WORKED NORMALLY WITH PADS FROM A DIFFERENT LOT NUMBER". LOG FILES HAVE BEEN SENT TO THE MANUFACTURER FOR INVESTIGATION. FROM THE LOG FILES INVESTIGATION, IT WAS FOUND ¿DEFI ELECTRODES DISCONNECTED EVENT" WHICH MEANS THAT THE PADS HAVE BEEN DISCONNECTED. THEREFORE, THE INVESTIGATION OUTCOME IS THAT THE ISSUE WAS RELATED TO THE PADS. THE TEMPUS LS DEVICE ITSELF WORKED CORRECTLY. THE LEGAL MANUFACTURER OF THE PADS IS NISSHA AND THE LEGAL MANUFACTURER OF THE PADS WAS INFORMED ABOUT THE LATEST COMPLAINTS INVOLVING TEMPUS LS PADS, INCLUDING THIS ONE (EMAIL BY (B)(6)' ON 08.03.2022)

    Description of Event or Problem · 0

    THE COMPLAINT AS DESCRIBED BY THE CUSTOMER "THE CREW ENCOUNTERED A PERSON IN CARDIAC ARREST AND HAD DIFFICULTY GETTING THE DEFIBRILLATION ELECTRODES TO READ A RHYTHM. THE INITIAL PADS DISPLAYED A DASHED LINE AND THE MESSAGE ¿CHECK ELECTRODES¿. THE CREW REMOVED THE PADS, WHICH WERE REPORTED TO BE WELL ADHERED, AND RE-PREPARED THE SKIN. THE CREW THEN REPLACED THE PADS WITH A NEW SET. THE SECOND SET OF PADS ALSO DISPLAYED THE ¿CHECK ELECTRODES¿ MESSAGE AND A DASHED LINE. THE CREW THEN PLACED THE 3 LEAD MONITORING ELECTRODES TO CHECK THE PATIENT¿S RHYTHM AND FOUND THE PATIENT TO BE IN ASYSTOLE. TEMPUS PADS LOT Y010521-04 IT SHOULD BE NOTED THAT THE PADS WERE DISCONNECTED FROM THE INITIAL LS AND ATTACHED TO ANOTHER LS THAT WAS ON SCENE (7022.00925) AND THEY GAVE THE SAME ERROR MESSAGE. BOTH TEMPUS LS DEVICES HAVE SUBSEQUENTLY WORKED NORMALLY WITH PADS FROM A DIFFERENT LOT NUMBER".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1007882 TEMPUS LS - MANUAL LOW ENERGY DEBFIBRILLATOR LDD SCHILLER AG 00-3020 07613365002737

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death