BEUDAMED
    FDA Adverse Event Death Summary report: N

    TEMPUS LS - MANUAL

    MDR report key: 12391005 · Received August 31, 2021

    Report

    Report Number
    3003832357-2021-10002
    Event Type
    Death
    Date Received
    August 31, 2021
    Date of Event
    August 4, 2021
    Manufacturer
    SCHILLER AG
    Product Code
    LDD
    UDI-DI
    07613365002737
    PMA / PMN Number
    K200849
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 THE DEVICE FAILED TO DELIVER THERAPY ON PATIENT. PATIENT PASSED AWAY. INVESTIGATION ON LOG DATA AND FUNCTIONAL TEST ON THE DEVICE CONCLUDED THAT THE DEVICE HAS A NON REPRODUCIBLE PACER ISSUE - ERROR 26. CAUSE: COMMUNICATION TO DPM FAILED (PACEMAKER COMMUNICATION). 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.

    Description of Event or Problem · 0

    THE INCIDENT DESCRIBED AS FOLLOWS BY THE CUSTOMER - WHILE TREATING AN URGENT PATIENT, WE ATTEMPTED TO PACE. INITIALLY EVERYTHING WAS WORKING WE ACHIEVED MECHANICAL CAPTURE. ABOUT IN A MINUTE INTO PACING I NOTICED A CHANGE IN THE ECG PATTERN, A SLOW NEAR ASYSTOLE WAVEFORM, THE PACER HAD STOPPED PACING AND DISPLAYED AN ERROR MESSAGE "EDM EQUIPMENT". THE PACER WOULD NOT ALLOW US TO EVEN TO BEGIN ELECTRICAL THERAPY AGAIN. WE TRIED TO TROUBLE SHOOT THE DEVICE BY REAPPLYING THE LEADS AND UNPLUGGING AND PLUGGING THE WIRE BACK IN WITH NO CHANGE. PT CONDITION IMMEDIATELY DETERIORATED PASSED A POINT OF NO RETURN. ONCE D51 ARRIVED ON SCENE WITH HIS DEVICE WE ATTACHED OUR WIRE TO HIS AND THE PACER WORKED AS INTENDED WITHOUT ANY THERAPEUTIC RESULTS (PT'S ARM WAS TWITCHING WITH OUT A PULSE) AS THE PT WAS NOW IN ASYTOLE. THE CUSTOMER RECEIVED REPLACEMENT DEVICE. THE FAILURE DEVICE HAS BEEN SENT TO THE MANUFACTURER FOR INVESTIGATION. THE EVALUATION OF THE LOG FILES AND THE RESCUE FILES COINCIDE AND SHOW THE PACER ERROR. THIS ERROR COULD NOT BE REPRODUCED WITH THIS DEVICE AFTERWARDS. THEREFORE, IT MUST BE ASSUMED THAT THIS ERROR WAS AN INCORRECT MEASUREMENT OF THE CONTROL SYSTEM. NOTE: CRIT ERROR 26 PACER ¿ CURRENT MEASUREMENT ERROR, PULSE DURATION ERROR, OVERCURRENT ERROR, RATE OVERRUN ERROR AND OVERVOLTAGE ERROR.

    Additional Manufacturer Narrative · 1

    A USER REPORT WAS RECEIVED RELATED TO A REPORTED PATIENT DEATH 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.

    Description of Event or Problem · 1

    THE INCIDENT DESCRIBED AS FOLLOWS BY THE CUSTOMER WHILE TREATING AN URGENT PATIENT, WE ATTEMPTED TO PACE. INITIALLY EVERYTHING WAS WORKING WE ACHIEVED MECHANICAL CAPTURE. ABOUT IN A MINUTE INTO PACING I NOTICED A CHANGE IN THE ECG PATTERN, A SLOW NEAR ASYSTOLE WAVEFORM, THE PACER HAD STOPPED PACING AND DISPLAYED AN ERROR MESSAGE "EDM EQUIPMENT". THE PACER WOULD NOT ALLOW US TO EVEN TO BEGIN ELECTRICAL THERAPY AGAIN. WE TRIED TO TROUBLE SHOOT THE DEVICE BY REAPPLYING THE LEADS AND UNPLUGGING AND PLUGGING THE WIRE BACK IN WITH NO CHANGE. PT CONDITION IMMEDIATELY DETERIORATED PASSED A POINT OF NO RETURN. ONCE ARRIVED ON SCENE WITH HIS DEVICE WE ATTACHED OUR WIRE TO HIS AND THE PACER WORKED AS INTENDED WITHOUT ANY THERAPEUTIC RESULTS (PT'S ARM WAS TWITCHING WITH OUT A PULSE) AS THE PT WAS NOW IN ASYSTOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1299691 TEMPUS LS - MANUAL LOW ENERGY DEFIBRILLATOR LDD SCHILLER AG 00-3020 07613365002737

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death