BEUDAMED
    FDA Adverse Event Death Summary report: N

    AGILENT INFO CENTER

    MDR report key: 1659049 · Received April 12, 2010

    Report

    Report Number
    1218950-2010-00489
    Event Type
    Death
    Date Received
    April 12, 2010
    Report Date
    February 22, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K01109
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CALLED ASKING IF THEY COULD OBTAIN RETROSPECTIVE DATA ON A DISCHARGED PT. THE SOLUTIONS CENTER (SC) REPRESENTATIVE INFORMED THE CUSTOMER THAT SINCE A DISCHARGE WAS PERFORMED THE DATA COULD NO LONGER BE RETRIEVED. INITIAL ATTEMPTS TO CONTACT THE BIOMEDICAL ENGINEER WERE UNSUCCESSFUL. HOWEVER, AFTER REACHING THE BIOMEDICAL ENGINEER ON 09APR10, HE STATED THAT THE PT HAD EXPIRED. THE BIOMED ENGINEER STATED THAT THE STAFF WANTED THE RETROSPECTIVE DATA FOR REVIEW AND THE PT FILE. THERE WERE NO DEVICE ISSUES OR CONCERNS WITH THE DEVICE. THIS WAS PURELY INFORMATIONAL. (B) (4) INFORMED THE STAFF THAT SINCE A DISCHARGE OF THE PT WAS PERFORMED, THE DATA WAS NO LONGER ATTAINABLE. NO DEVICE MALFUNCTION OCCURRED AND THE ONLY USER ERROR WAS THE DISCHARGING OF THE PT BEFORE SAVING THE PT DATA. THERE IS NO INDICATION OF ANY ERROR RELATIVE TO PT CARE. NO FURTHER INVESTIGATION/ACTION IS WARRANTED. (B) (4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PT HAD EXPIRED AND THAT THEY WERE SEEKING RETROSPECTIVE DATA AND THE PT FILE FOR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGILENT INFO CENTER MHX, DRT MHX PHILIPS MEDICAL SYSTEMS M3150A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death