BEUDAMED
    FDA Adverse Event Death Summary report: N

    CMS MAIN FRAME

    MDR report key: 3001645 · Received March 7, 2013

    Report

    Report Number
    9610816-2013-00054
    Event Type
    Death
    Date Received
    March 7, 2013
    Date of Event
    January 26, 2013
    Report Date
    February 14, 2013
    Manufacturer
    PHILIPS MEDICLA SYSTEMS
    Product Code
    DRT
    PMA / PMN Number
    K002758
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED TO PHILIPS TECHNICAL SUPPORT THAT THE PT DIED AND HE WAS FOUND UNSCOPED. THE CUSTOMER CANNOT CONFIRM IF THE PT HAD ECG LEADS AT THE TIME OF THE INCIDENT. THE CUSTOMER HAS ALLEGED THAT THE PRODUCT CONTRIBUTED TO THE EVENT, HOWEVER THE HOSPITAL'S BIOMED TESTED THE DEVICE AND COULD NOT FIND ANY MALFUNCTION. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION REGARDING THIS INCIDENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO PHILIPS TECHNICAL SUPPORT THAT THE PT DIED AND HE WAS FOUND UNSCOPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97651 CMS MAIN FRAME DRT PHILIPS MEDICLA SYSTEMS M1046A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death