BEUDAMED
    FDA Adverse Event Death Summary report: N

    TEMPUS LS-MANUAL

    MDR report key: 16742477 · Received April 14, 2023

    Report

    Report Number
    3003832357-2023-00216
    Event Type
    Death
    Date Received
    April 14, 2023
    Date of Event
    April 8, 2023
    Manufacturer
    SCHILLER AG
    Product Code
    LDD
    UDI-DI
    07613365002737
    PMA / PMN Number
    K200849
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BASED ON INFORMATION PROVIDED BY REMOTE SERVICE ENGINEER RSE AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS LS MANUAL INDICATING A PACING DPM HARDWARE FAILURE. THE PATIENT EXPIRED IN THE EMERGENCY ROOM. THE COMPLAINT WAS ESCALATED FOR TECHNICAL INVESTIGATION TO THE ORIGINAL EQUIPMENT MANUFACTURER, SCHILLER. SCHILLER¿S INVESTIGATION SHOWED THAT THE CONNECTOR (PACER BOARD) WAS COMPLETELY UNPLUGGED. THE REASON FOR THE UNPLUGGING WAS THAT THE PACER BOARD WAS NOT GLUED PROPERLY BECAUSE THE TAPE WAS FOLDED INSTEAD OF BEING FLAT. THIS THEN LED TO THE COMPLETE UNPLUGGING OF THE PACER BOARD AND ACCORDINGLY TO THE DPM HARDWARE FAILURE. BASED ON THE INFORMATION AVAILABLE AND ANALYSIS CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS AN UNPLUGGED PACER BOARD. THE REPORTED PROBLEM WAS CONFIRMED. BASED ON THE INFORMATION AVAILABLE AND RESULTS OF ADDITIONAL ANALYSIS, NO FURTHER ACTION IS NECESSARY AT THIS TIME. A CLINICAL HARM REVIEW WAS PERFORMED BY A PHILIPS PMS CLINICAL EXPERT AND THIS EVENT IS ASSESSED AS RELATED TO A PRODUCT PROBLEM WITH THE DEVICE. THIS EVENT IS BOTH UNLABELLED AND NOT PREDICTED. 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 CUSTOMER WAS PROVIDED A REPLACEMENT DEVICE TO RESOLVE THE ISSUE. IT HAS BEEN CONCLUDED THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Additional Manufacturer Narrative · 0

    TYPE OF REPORTED COMPLAINT UPDATED TO DEATH. DATE OF DEATH (B)(6) 2024

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED PHILIPS THAT TEMPUS LS HAS PACING DPM HARDWARE FAILED . WHILE WORKING A PATIENT WITH A VERY LOW AN DIMINISHING HEART RATE, EMS TRIED TO PACE THE PATIENT AND UNIT DISPLAYED "DPM HARDWARE FAILURE". PATIENT DIED AT THE EMERGENCY ROOM. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. FURTHER UPDATES WILL BE PROVIDED WHEN THE INVESTIGATION IS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1143737 TEMPUS LS-MANUAL LOW ENERGY DEFIBRILLATOR LDD SCHILLER AG 00-3020 07613365002737

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death