BEUDAMED
    FDA Adverse Event Death Summary report: N

    TEMPUS LS-MANUAL

    MDR report key: 15360799 · Received September 6, 2022

    Report

    Report Number
    3003832357-2022-00025
    Event Type
    Death
    Date Received
    September 6, 2022
    Date of Event
    August 8, 2022
    Manufacturer
    SCHILLER AG
    Product Code
    LDD
    UDI-DI
    07613365002737
    PMA / PMN Number
    K200849
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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 DISPLAY ECG WAVEFORMS DURING PATIENT CARE. THE COMPLAINT WAS ESCALATED FOR TECHNICAL INVESTIGATION . THE INVESTIGATIONS INVOLVED A "GOOD FAITH EFFORT" TO OBTAIN INFORMATION AND THE DEVICE FOR THE INVESTIGATION. DESPITE ALL THE EFFORTS, SCHILLER THE MANUFACTURER WAS NOT ABLE TO OBTAIN THE REQUESTED INFORMATION AND DEVICE. THEREFORE, NEITHER INVESTIGATION COULD BE DONE NOR ROOT CAUSE COULD BE DETERMINED. THE DEVICE WAS REPLACED FOR THE CUSTOMER. 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. HE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    AS DESCRIBED BY THE CUSTOMER 'UNIT FAILED TO DISPLAY DURING PATIENT CARE' DURING EVALUATION STAGE, CUSTOMER CONFIRMED DEATH OF PATIENT. UNIT WOULD NOT DISPLAY ECG WAVEFORMS DURING PATIENT MONITORING. PHILIPS RDT PLANNING TO RECEIVE THE DEVICE FOR THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2501870 TEMPUS LS-MANUAL LOW ENERGY DEFIBRILLATOR LDD SCHILLER AG 00-3020 07613365002737

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death