BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPUS LS-MANUAL

    MDR report key: 15803660 · Received November 16, 2022

    Report

    Report Number
    3003832357-2022-00050
    Event Type
    Malfunction
    Date Received
    November 16, 2022
    Date of Event
    October 19, 2022
    Report Date
    July 30, 2024
    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
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE DESCRIPTION PROVIDED BY THE CUSTOMER, THIS DEVICE HAD SOME PACING ISSUE. NEITHER THE DEVICE NOR THE LOGFILES WERE PROVIDED BY THE CUSTOMER. THE INVESTIGATIONS INVOLVED A "GOOD FAITH EFFORT" TO OBTAIN INFORMATION AND THE DEVICE FOR THE INVESTIGATION. DESPITE ALL THE EFFORTS, SCHILLER AG WAS NOT ABLE TO OBTAIN THE REQUESTED INFORMATION AND DEVICE. THEREFORE, NEITHER INVESTIGATION COULD BE DONE NOR ROOT CAUSE COULD BE DETERMINED. CUSTOMER CONFIRMED THAT THE PATIENT WAS NOT INVOLVED, ISSUE OCCURRED DURING PM. 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. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Additional Manufacturer Narrative · 0

    DEVICE PROBLEM CODE AND METHOD CODE UPDATED.

    Additional Manufacturer Narrative · 0

    CORRECTION: COMPONENT CODE UPDATED TO INSUFFICIENT INFORMATION. NEITHER THE DEVICE NOR THE LOG FILES WERE PROVIDED BY THE CUSTOMER. THE INVESTIGATIONS INVOLVED A "GOOD FAITH EFFORT" TO OBTAIN INFORMATION AND THE DEVICE FOR THE INVESTIGATION. DESPITE ALL THE EFFORTS, SCHILLER WAS NOT ABLE TO OBTAIN THE REQUESTED INFORMATION AND DEVICE. THEREFORE, NEITHER INVESTIGATION COULD BE DONE NOR ROOT CAUSE COULD BE DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Additional Manufacturer Narrative · 0

    UPDATED EVALUATION METHOD CODE, EVALUATION RESULT CODE AND COMPONENT CODE.

    Description of Event or Problem · 0

    CUSTOMER REPORTED TEMPUS LS DEVICE PACER WAS NOT WORKING. A USER REPORT WAS RECEIVED RELATED TO A REPORTED PRODUCT PROBLEM 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 THE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 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 THE PACER IS NOT WORKING.

    Description of Event or Problem · 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 THE PACER IS NOT WORKING. THE CUSTOMER CONFIRMED THAT THE PATIENT WAS NOT INVOLVED, THE ISSUE OCCURRED DURING PREVENTIVE MAINTENANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355562 TEMPUS LS-MANUAL LOW ENERGY DEFIBRILLATOR LDD SCHILLER AG 00-3020 07613365002737

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other