BEUDAMED
    FDA Adverse Event Death Summary report: N

    TEMPUS LS-MANUAL

    MDR report key: 14834263 · Received June 27, 2022

    Report

    Report Number
    3003832357-2022-00011
    Event Type
    Death
    Date Received
    June 27, 2022
    Date of Event
    April 12, 2022
    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
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FURTHER INFORMATION HAS BEEN RECEIVED REGARDING THIS EVENT ON 5TH JULY 2022 - IT HAS BEEN CONFIRMED THAT THE PATIENT INVOLVED DIED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS REMOTE SERVICE ENGINEER AND SCHILLER INVESTIGATION TEAM AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS LS INDICATING THAT DEVICE FAILED TO SHOW ECG WAVEFORMS EVEN AFTER PADS WERE SWITCHED OUT, REQUESTING EXCHANGE PART. RDT INFORMED SCHILLER AG THE MANUFACTURER , THAT THE PATIENT INVOLVED IN THIS CASE DIED. THE DEVICE WAS USED INITIALLY IN THIS INTERVENTION AND WAS NOT ABLE TO RECORD ANY ECG SIGNAL. THE DEVICE WAS ARRIVED AT SCHILLER AG ON 2022-07-12 AND WAS TESTED SUCCESSFULLY WITH NO DEVICE FAILURE FOUND. THE INTERNAL TESTS AND INVESTIGATION SHOWED THAT THE DEVICE WORKED AS INTENDED. NO MALFUNCTIONS WERE DISCOVERED. THE LOG-FILES AND THE RESCUE-FILES SHOW THE SAME DATA: IT SEEMS THAT THE DEVICE WAS WORKING CORRECTLY. IT IS NOT CLEAR WHY THE PADS ECG WAS ONLY RECORDED FOR 2S, BUT THE DEVICE CORRECTLY DETECTED THE DISCONNECTION AND DISPLAYED ¿CHECK DEFIBRILLATION ELECTRODES¿ AS INTENDED. AS NO MALFUNCTIONS WERE DISCOVERED, THE DISCONNECTS MUST BE RELATED EITHER TO THE DEFIBRILLATOR PADS OR PATIENT'S CONDITION. THE DATA ENTERED IN THIS COMPLAINT RECORD WILL BE UTILIZED FOR PRODUCT QUALITY AND SAFETY IMPROVEMENTS PER THE POST MARKET SURVEILLANCE AND RISK MANAGEMENT PROCESSES. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Description of Event or Problem · 0

    AS CUSTOMER DESCRIBED 'NO ECG WAVEFORMS EVEN AFTER PADS WERE SWITCHED OUT, REQUESTING EXCHANGE PART'. PHILIPS RDT PLANNING TO RECEIVE THE DEVICE AND SEND TO THE MANUFACTURER FOR THE ROOT CAUSE INVESTIGATION.

    Description of Event or Problem · 0

    AS CUSTOMER DESCRIBED 'NO ECG WAVEFORMS EVEN AFTER PADS WERE SWITCHED OUT, REQUESTING EXCHANGE PART'. PHILIPS RDT PLANNING TO RECEIVE THE DEVICE AND SEND TO THE MANUFACTURER FOR THE ROOT CAUSE INVESTIGATION. FURTHER INFORMATION HAS BEEN RECEIVED REGARDING THIS EVENT ON 5TH JULY 2022 - IT HAS BEEN CONFIRMED THAT THE PATIENT INVOLVED DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1937533 TEMPUS LS-MANUAL LOW ENERGY DEFIBRILLATOR LDD SCHILLER AG 00-3020 07613365002737

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death| O