BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPUS LS - MANUAL

    MDR report key: 23424625 · Received October 30, 2025

    Report

    Report Number
    3003832357-2025-000809
    Event Type
    Malfunction
    Date Received
    October 30, 2025
    Date of Event
    July 11, 2025
    Report Date
    November 25, 2025
    Manufacturer
    SCHILLER AG
    Product Code
    LDD
    UDI-DI
    07613365002737
    PMA / PMN Number
    K200849
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PREVIOUSLY REPORTED ON (B)(4) WITH MDR # 3003832357-2025-000598. A COMPLAINT INVESTIGATION HAS BEEN CONDUCTED ON (B)(4) WITH MDR # 3003832357-2025-000598.

    Description of Event or Problem · 0

    THIS REPORT IS BASED ON INFORMATION PROVIDED BY REMOTE SERVICE ENGINEER RSE, PHILIPS FIELD SERVICE ENGINEER FSE AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS LS MAN DEFIBRILLATOR, INDICATING THAT THE UNIT FAILED PREVENTIVE MAINTENANCE, NO AUDIBLE ALERTS WHEN THE ECG CABLES WERE DETACHED. THE DEVICE WAS NOT IN USE DURING THIS EVENT, THEREFORE NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2250884 TEMPUS LS - MANUAL LOW ENERGY DEFIBRILLATOR LDD SCHILLER AG 00-3020 07613365002737

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other