BEUDAMED
    FDA Adverse Event Death Summary report: N

    TEMPUS LS-MANUAL

    MDR report key: 14834215 · Received June 27, 2022

    Report

    Report Number
    3003832357-2022-00010
    Event Type
    Death
    Date Received
    June 27, 2022
    Date of Event
    April 12, 2022
    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
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN RECEIVED REGARDING THIS EVENT ON 5TH JULY 2022 - IT HAS BEEN CONFIRMED THAT THE PATIENT INVOLVED DIED.

    Additional Manufacturer Narrative · 0

    PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS LS INDICATING NO APPEARANCE OF ECG WAVEFORMS EVEN AFTER PADS WERE SWITCHED OUT. THE DEVICE ARRIVED AT SCHILLER THE MANUFACTURER ON 2022-07-12 AND WAS TESTED SUCCESSFULLY WITH NO DEVICE FAILURE FOUND. THE DEVICE WAS OPERATED IN MANUAL MODE DURING THE ENTIRE INTERVENTION. THEREFORE, THE CUSTOMER WAS REPORTED ABOUT THE PAD ECG. THE LOG-FILES AND THE RESCUE-FILES SHOW THE SAME DATA AS NO PROBLEM IN THE DEVICE. IT WAS CONCLUDED THAT THE DEVICE WAS WORKING CORRECTLY. IT IS NOT CLEAR WHY THE PADS ECG LOST CONNECTION, BUT THE LOSS OF CONNECTION WAS DETECTED BY THE DEVICE AND THE DEVICE STATE ALWAYS ¿CHECK DEFIBRILLATION ELECTRODES¿. NO MALFUNCTION WAS DETECTED DURING INTERNAL TESTING AND THERE WAS NO VISIBLE DAMAGE ON THE DEVICE. BASED ON THE AVAILABLE INFORMATION, THE DEVICE WORKED AS INTENDED AND DID NOT CONTRIBUTE TO THE LOSS OF CONNECTION. 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.

    Additional Manufacturer Narrative · 0

    UPDATED PROBLEM CODE GRID TO REFLECT INVESTIGATION RESULTS PROVIDED ON MFR #3003832357-2022-00010.

    Description of Event or Problem · 0

    AS CUSTOMER DESCRIBED 'NO ECG WAVEFORMS EVEN AFTER PADS WERE SWITCHED OUT, REQUESTING EXCHANGE PART'. PHILIPS RDT PLANNING TO RECEIVE THE DEVICE AND SEND TO THE MANUFACTURER FOR THE ROOT CAUSE INVESTIGATION.

    Description of Event or Problem · 0

    AS CUSTOMER DESCRIBED 'NO ECG WAVEFORMS EVEN AFTER PADS WERE SWITCHED OUT, REQUESTING EXCHANGE PART'. PHILIPS RDT PLANNING TO RECEIVE THE DEVICE AND SEND TO THE MANUFACTURER FOR THE ROOT CAUSE INVESTIGATION. ADDITIONAL INFORMATION HAS BEEN RECEIVED REGARDING THIS EVENT ON (B)(6) 2022 - IT HAS BEEN CONFIRMED THAT THE PATIENT INVOLVED DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910270 TEMPUS LS-MANUAL LOW ENERGY DEFIBRILLATOR LDD SCHILLER AG 00-3020 07613365002737

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death| O