BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPUS LS-MANUAL

    MDR report key: 14854432 · Received June 29, 2022

    Report

    Report Number
    3003832357-2022-00013
    Event Type
    Malfunction
    Date Received
    June 29, 2022
    Date of Event
    November 23, 2021
    Manufacturer
    SCHILLER AG
    Product Code
    LDD
    UDI-DI
    07613365002737
    PMA / PMN Number
    K200849
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS LS EXHIBITING APS CONFIGURATION ERROR. ERROR COMES ON DEVICE WHEN POWERED ON. THE DEVICE SENT TO SCHILLER FOR INVESTIGATION. NO DEVICE FAILURE FOUND DURING THE ENTRY TEST. THE INVESTIGATION ON THE LOG FILE SHOWED THAT THIS ERROR MESSAGE WAS LOGGED ONLY ONCE - NOT REPRODUCIBLE. DURING START-UP THE ECG MICROCHIP IS CONFIGURED WITH THE SYSTEM PARAMETERS. ONLY WHEN THE ECG MICROCHIP CANNOT BE CONFIGURED SUCCESSFULLY, THE DEVICE DISPLAYS THIS ERROR MESSAGE. AS THE ERROR IS NOT REPRODUCIBLE SAG CANNOT DETERMINE WHAT TRIGGERED THIS ERROR. 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.

    Description of Event or Problem · 0

    AS CUSTOMER DESCRIBED 'APS CONFIGURATION ERROR. ERROR COMES ON DEVICE WHEN POWERED ON. PHILIPS RDT PLANNING TO RECEIVE THE DEVICE AND SEND TO THE MANUFACTURER FOR THE ROOT CAUSE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154481 TEMPUS LS-MANUAL LOW ENERGY DEFIBRILLATOR LDD SCHILLER AG 00-3020 07613365002737

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other