BEUDAMED
    FDA Adverse Event Other Summary report: N

    E.M.E.

    MDR report key: 1038762 · Received May 2, 2008

    Report

    Report Number
    2021710-2008-00039
    Event Type
    Other
    Date Received
    May 2, 2008
    Date of Event
    April 3, 2008
    Report Date
    May 2, 2008
    Manufacturer
    CARDINAL HEALTH 207, INC
    Product Code
    MNT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INCIDENT OCCURRED AT HOSP. NEITHER THE USER FACILITY NOR THE DISTRIBUTOR SUBMITTED A USER FACILITY/DISTRIBUTOR REPORT TO THE MFR. CARDINAL HEALTH IN CONJUNCTION WITH AN INDEPENDENT LAB PREVIOUSLY PERFORMED AN INVESTIGATION/EVAL OF THE POWER SUPPLY AND DETERMINED THAT THIS POWER SUPPLY IS NOT A COMPLIANT. CARDINAL HEALTH INITIATED A QUALIFICATION TEST PLAN AND DESIGN VERIFICATION PLAN TO QUALIFY A PERFORMANCE COMPATIBLE AND IEC COMPLIANT POWER SUPPLY FROM A DIFFERENT POWER SUPPLY MFR TO USE WITH THE E.M.E. INFANT FLOW PA. ON OCT. 23, 2007 AN ENGINEERING CHANGE ORDER (ECO) RELEASED THE NEW POWER SUPPLY FOR USE WITH THIS DEVICE. CARDINAL HEALTH CONDUCTED A RISK ANALYSIS AND DETERMINED THAT THE RISK TO HEALTH IS NEGLIGIBLE.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CARDINAL HEALTH TECH SUPPORT SPECIALIST IN RESPONSE TO AN E-MAIL FROM VIASYS REP. "RECEIVED EMAIL: THEY ARE REPORTING THAT THIS UNIT IS GIVING SHOCKS WHEN TO USERS WHEN THEY TOUCH THE CASE AND GROUND. VIASYS IS GOING TO HAVE THE CUSTOMER SEND THEM THE UNIT AND THEY ARE GOING TO EXCHANGE THE POWER SUPPLIES SINCE WE HAVE RELEASED A NEW POWER SUPPLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E.M.E. CONTINOUS POSITIVE AIRWAY PRESS UNIT MNT CARDINAL HEALTH 207, INC M672PA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other