BEUDAMED
    FDA Adverse Event Death Summary report: N

    PHILIPS TC02 MODULE

    MDR report key: 1736101 · Received June 22, 2010

    Report

    Report Number
    9610816-2010-00214
    Event Type
    Death
    Date Received
    June 22, 2010
    Date of Event
    May 24, 2010
    Report Date
    June 15, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    KLK
    PMA / PMN Number
    K925910
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER ALLEGED THAT THE TCGAS MODULE FAILED TO CALIBRATE PROPERLY AND FAILED TO PROVIDE ACCURATE MEASUREMENT DATA. THE AVAILABLE INFO DOES NOT SUPPORT THAT THERE WAS ANY DEVICE MALFUNCTION OR THAT THE USE OF THIS DEVICE WAS A FACTOR IN A DEATH. PHILIPS IS IN THE PROCESS OF OBTAINING ADD'L INFO REGARDING THIS INCIDENT, AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED. (B) (4).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THAT THE TCGAS MODULE FAILED TO CALIBRATE PROPERLY AND FAILED TO PROVIDE ACCURATE MEASUREMENT DATA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILIPS TC02 MODULE KLK PHILIPS MEDICAL SYSTEMS M1018A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death