BEUDAMED
    FDA Adverse Event Death Summary report: N

    M3155 RELEASE L.0 UPGRADE

    MDR report key: 2521347 · Received April 2, 2012

    Report

    Report Number
    1218950-2012-01019
    Event Type
    Death
    Date Received
    April 2, 2012
    Report Date
    March 21, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS-DUP
    Product Code
    MHX
    PMA / PMN Number
    K062271
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THEIR PHILIPS INFO CENTER DID NOT SAVE ANY DATA FOR ALL PTS ADMITTED. THIS ISSUE WOULD NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY AS REAL-TIME MONITORING AND ALARM ANNUNCIATION FUNCTIONS ARE UNAFFECTED. RETROSPECTIVE DATA REPRESENTS DATA STORED IN REVIEW APPLICATIONS. THIS DATA IS NOT STORED WITHIN THE PRODUCT AS A PERMANENT ARCHIVE AND CAN BE MANUALLY DELETED OR AUTOMATICALLY DELETED OVER TIME. PRODUCT LABELING INTELLIVUE INFO CENTER INSTRUCTIONS FOR USE. VERSION L. PAGE IV CONTAINS THE FOLLOWING "WARNING: ALWAYS CONFIRM INFO CENTER OBSERVATIONS WITH CLINICAL OBSERVATIONS OF PT AT THE BEDSIDE BEFORE ADMINISTERING INTERVENTIONS". 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR PHILIPS INFO CENTER DID NOT SAVE ANY PT DATA FOR ALL PTS ADMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M3155 RELEASE L.0 UPGRADE MHX PHILIPS MEDICAL SYSTEMS-DUP M3155

    Patients

    Seq Age Sex Outcome Treatment
    1 Death