BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPUS LS-MANUAL

    MDR report key: 17429661 · Received July 31, 2023

    Report

    Report Number
    3003832357-2023-00505
    Event Type
    Injury
    Date Received
    July 31, 2023
    Date of Event
    May 9, 2022
    Manufacturer
    SCHILLER AG
    Product Code
    LDD
    PMA / PMN Number
    K200849
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS LS INDICATING THAT THE CUSTOMER TRIED TO PACE A PATIENT AND THE DEVICE COMMUNICATED HARDWARE FAILURE. THE SCHILLER INVESTIGATED THE REPORTED PROBLEM BASED ON THE PROVIDED LOGFILES OF THE DEVICE AND CONFIRMED LOG FILE SHOWED THAT THE ISSUE IS MOST LIKELY TO BE RELATED TO AN INTERMITTENT "ERROR 26" ISSUE. THE PACER STOPPED DUE TO THE ERROR 26. HOWEVER, THE TRIGGER AND ACTUAL ROOT CAUSE OF THE ERROR 26 CANNOT BE CONCLUDED AT THIS STAGE. THE DEFECTIVE DEVICE SENT TO THE LOANER POOL FOR DPM REWORK AT SCHILLER. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1899532 TEMPUS LS-MANUAL LOW ENERGY DEFIBRILLATOR LDD SCHILLER AG 00-3020

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other