BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPUS LS-MANUAL

    MDR report key: 14474028 · Received May 23, 2022

    Report

    Report Number
    3003832357-2022-00004
    Event Type
    Injury
    Date Received
    May 23, 2022
    Date of Event
    April 23, 2022
    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

    A USER REPORT WAS RECEIVED RELATED TO A REPORTED PATIENT HARM 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 INVESTIGATION HAS PROGRESSED.

    Additional Manufacturer Narrative · 0

    PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS LS INDICATING THAT THE DEVICE DID NOT RECOGNIZE THE LEADS. CASE ESCALATED TO TECHNICAL INVESTIGATION. INVESTIGATION PERFORMED ON LOG- AND RESCUE-FILES BY RESEARCH & DEVELOPMENT DEPARTMENT. THE SUPPORTED RESCUE-FILES AND THE FULL DISCLOSURE FORM SHOWED THE SAME DATA. DURING THE WHOLE INTERVENTION NO PADS WHERE ATTACHED, EXPECT AT 13:29:30-13:29:23 (UTC-4) (RESCUE-FILE 19:29:30-19:29:31 (UTC+2)). IN THE RESCUE-FILE ECG LEAD II WAS RECORDED FROM 19:30:22-19:32:52. IN THE FULL DISCLOSURE FROM TEMPUS PRO THE SAME ECG WAS RECORDED (13:30:22-13:32:52). AFTER THIS TIME BOTH FILES DO NOT SHOW ANY ECG LEAD II SIGNALS. ON 14.04.2022 THE DEVICE WAS ONLY USED IN MANUAL MODE (4) AND THEREFORE THE CONNECTED ECG ON LEAD II WAS NEVER SHOWED ON THE DISPLAY, BUT IT SEEMS TO BE TRANSMITTED TO THE TEMPUS PRO (DEVICE OF RDT PHILIPS). BASED ON THE PROVIDED EVENT DESCRIPTION, IT ASSUMED THAT THE HCP WAS EXPECTING THE TEMPUS LS MANUAL TO DISPLAY AN ECG SIGNAL FROM THE ECG LEADS. THE ECG LEADS AS PER SPECIFICATION ARE ONLY DISPLAYED IN MONITOR OR PACER MODE. BASED ON THESE RESULTS, A USE ERROR CAN BE ASSUMED. 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. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE REOPENED.

    Additional Manufacturer Narrative · 0

    COMPONENT CODE GRID UPDATED TO REFLECT INVESTIGATION PREVIOUSLY REPORTED ON MFR#: 3003832357-2022-00004.

    Description of Event or Problem · 0

    THE CUSTOMER DESCRIBED THE PROBLEM AS 'UNABLE TO PICK UP THE LEADS'. FURTHER DETAILS ABOUT THE INCIDENT AND DETAILS RELATED PATIENT HARM IS AWAITED FROM THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219028 TEMPUS LS-MANUAL LOW ENERGY DEFIBRILLATOR LDD SCHILLER AG 00-3020 07613365002737

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other