BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPUS LS-MANUAL

    MDR report key: 19077382 · Received April 10, 2024

    Report

    Report Number
    3003832357-2024-00303
    Event Type
    Injury
    Date Received
    April 10, 2024
    Date of Event
    March 29, 2024
    Report Date
    October 9, 2024
    Manufacturer
    SCHILLER AG
    Product Code
    LDD
    UDI-DI
    07613365002737
    PMA / PMN Number
    K200849
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CONCLUSION UPDATED DUE TO NEW INFORMATION RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THERE WAS A DPM ERROR WHILE PACING. NO PATIENT HARM OR INJURY HAS BEEN REPORTED. FURTHER INFORMATION WILL BE SEND UPON COMPLETION OF THE MANUFACTURER'S INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413330 TEMPUS LS-MANUAL LOW ENERGY DEFIBRILLATOR LDD SCHILLER AG 07613365002737

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other