BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPUS LS-MANUAL

    MDR report key: 16271115 · Received January 31, 2023

    Report

    Report Number
    3003832357-2023-00023
    Event Type
    Injury
    Date Received
    January 31, 2023
    Date of Event
    January 3, 2023
    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 DUE TO CONNECTION ISSUES, DEFIBRATION WAS DELAYED. LS LOG SHOWS PADS ON/PADS OFF SEVERAL TIMES BEFORE DEFIBRATION WAS DONE. THE COMPLAINT WAS ESCALATED FOR TECHNICAL INVESTIGATION AND THE DEVICE WAS TESTED AND WAS FOUND TO BE WORKING FINE. THE TEAM COMMENTED, THAT THERE MIGHT HAVE BEEN SOMETHING LOOSE ON THE DEFIBRILLATOR PADS OR THE WAY THEY WERE PLACED. FINDINGS FROM R&D ARE AS FOLLOWS: ALL OTHER CONNECTIONS IN THE SIGNAL PATH ARE RELIABLE. WHEN A SIMULATOR IS CONNECTED, THIS BEHAVIOUR IS NOT OCCURRING. SO IT IS RELATED TO THE CABLE AND THE ATTACHMENTS OF THE PADS IN PARTICULAR. 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. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TEMPUS LS - DUE TO CONNECTION ISSUES, DEFIBRILLATION WAS DELAYED. LS LOG SHOWS PADS ON/PADS OFF SEVERAL TIMES BEFORE DEFIBRILLATION WAS DONE. A USER REPORT WAS RECEIVED RELATED TO A REPORTED PRODUCT PROBLEM WHICH IS CURRENTLY BEING INVESTIGATED. FURTHER UPDATES WILL BE PROVIDED WHEN THE INVESTIGATION IS IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1991223 TEMPUS LS-MANUAL LOW ENERGY DEFIBRILLATOR LDD SCHILLER AG 07613365002737

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other