BEUDAMED
    FDA Adverse Event Other Summary report: N

    E.M.E.

    MDR report key: 1038763 · Received May 2, 2008

    Report

    Report Number
    2021710-2008-00038
    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 PN: 674-037 POWER SUPPLY AND DETERMINED THAT THIS POWER SUPPLY IS NOT IEC 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 FROM VIASYS ANOTHER COUNTRY: I HAVE A REPORT ON THIS UNIT GIVING SHOCKS TO USERS WHEN THEY TOUCH THE INFANT FLOW CASE AND GROUND. SEEMS TO BE THE "OLD STYLE" SLIM POWER PACKS. VIASYS IS JUST ASKING FOR US TO DOCUMENT THE COMPLAINT, SINCE WE HAVE ALREADY CHANGED THE POWER SUPPLY. THEY ARE HAVING THE CUSTOMER SEND IN THE UNIT TO THEM AND THEY ARE EXCHANGING THE POWER SUPPLY TO THE NEW ON."

    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