BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPUS LS-MANUAL

    MDR report key: 17596002 · Received August 22, 2023

    Report

    Report Number
    3003832357-2023-00554
    Event Type
    Injury
    Date Received
    August 22, 2023
    Date of Event
    July 12, 2021
    Manufacturer
    SCHILLER AG
    Product Code
    LDD
    PMA / PMN Number
    K200849
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 PACE THE PATIENT. PATIENT OUTCOME IS UNKNOWN. THE CUSTOMER WAR PROVIDED WITH THE REPLACEMENT DEVICE. DEVICE RECEIVED AT SAG FOR INVESTIGATION. FROM THE REVIEW OF THE PROVIDED LOG FILES, THERE DO NOT SEEM TO BE ANY SIGNS OF ERROR 26 HAVING OCCURRED. RESULTS OF FUNCTIONAL TESTING INDICATE THAT THE DEVICE IS WORKING AS INTENDED. THE ONLY CONCERN WAS THE MEASURED POWER CONSUMPTION, WHILE POWERED OFF, SEEMS TO BE OUT OF THE ALLOWED PARAMETERS. THERE WAS NOT ANY MENTION OF DATE, WHEN THE PROBLEM REPORTEDLY OCCURRED BUT R&D CHECKED FOR PACING ERRORS AND SAW NO ERROR 26 AND NOTED THAT THE DEVICE NEVER ENTERED PACER MODE. SAG REQUESTED MORE INFORMATION ON THE CASE, TO CONFIRM THAT THERE WAS NO CONFUSION ON THE END USER SIDE. LOCAL MARKED FAILED TO OBTAIN NECESSARY INFORMATION. THE DEVICE IS ABLE TO PACE AS INTENDED, THE COMPLAINT IS UNCONFIRMED. 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 DEVICE WAS CONFIRMED TO BE OPERATING PER SPECIFICATIONS AND NO FAILURE WAS IDENTIFIED. 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

    PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS LS INDICATING THAT THE DEVICE FAILED TO PACE. THE COMPLAINT WAS ESCALATED FOR TECHNICAL INVESTIGATION AND THE RESULTS INDICATE THAT THE DEVICE IS ABLE TO PACE NORMALLY, SCHILLER MANUFACTURING REPAIR TEAM DID THE INCOMING INSPECTION. THE DEVICE WAS TESTED AND PASSED EVERYTHING UNTIL THE POINT WHERE THE POWER-OFF CURRENT CONSUMPTION IS CHECKED. THERE WAS NOT ANY MENTION OF THE DATE WHEN THE PROBLEM REPORTEDLY OCCURRED BUT OUR R&D SOFTWARE ENGINEER CHECKED FOR PACING ERRORS AND SAW NO ERROR 26 AND NOTED THAT THE DEVICE NEVER ENTERED PACER MODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45829 TEMPUS LS-MANUAL LOW ENERGY DEFIBRILLATOR LDD SCHILLER AG 00-3020

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other