BEUDAMED
    FDA Adverse Event Death Summary report: N

    TEMPUS LS

    MDR report key: 17186713 · Received June 22, 2023

    Report

    Report Number
    3003832357-2023-00404
    Event Type
    Death
    Date Received
    June 22, 2023
    Date of Event
    May 17, 2023
    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
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE CREW RESPONDED TO CARDIAC ARREST ON (B)(6) 2023. WHEN THE CREW OPENED THE PADS, ALL THE GEL WAS IN THE BOTTOM CORNER OF THE PAD(S) AND THREE-FOURTHS OF IT HAD NO GEL. THIS WAS CORRECTED WITH ANOTHER SET OF PADS. THE PATIENT WAS ASYSTOLIC (FLAT LINE) ON EMS ARRIVAL, THEREFORE NO ATTEMPT AT ANY TYPE OF ENERGY DELIVERY OCCURRED. THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1028037 TEMPUS LS LOW ENERGY DEFIBRILLATOR LDD SCHILLER AG 00-3020 07613365002737

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Female Death