BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON CARDIOLOGY

    MDR report key: 5008666 · Received August 13, 2015

    Report

    Report Number
    9616760-2015-00002
    Event Type
    Malfunction
    Date Received
    August 13, 2015
    Date of Event
    July 13, 2015
    Report Date
    August 12, 2015
    Manufacturer
    MCKESSON ISRAEL LTD.
    Product Code
    LLZ
    PMA / PMN Number
    K112720
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE OF THE ISSUE IS CURRENTLY UNKNOWN AND IS UNDER INVESTIGATION. (B)(4) WILL PROVIDE A FOLLOW UP REPORT TO THE AGENCY ONCE ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    THE REPORTING FACILITY ALLEGED THAT THE ECHO IMAGES FOR PATIENT A WERE INADVERTENTLY SENT TO THE FOLDER OF PATIENT B, WHOSE FOLDER SUBSEQUENTLY CONTAINED THE WRONG ECHO IMAGES. THE ISSUE OCCURRED AT 4:20 PM. AS A RESULT OF THIS ISSUE, PATIENT B WAS TRANSFERRED TO THE CARDIAC CARE UNIT (CCU) AT APPROXIMATELY 6:30 PM, AFTER THE DEPARTMENT RECEIVED THE WRONG ECHO IMAGES. THE ISSUE WAS DISCOVERED WHEN THE REPORTING FACILITY STAFF REVIEWED PATIENT B'S RECORDS THAT EVENING. PATIENT A'S ECHO IMAGES HAVE NOT BEEN AFFECTED, SO THERE ARE NO CONSEQUENCES TO PATIENT A AS A RESULT OF THIS ISSUE AND THERE HAS BEEN NO REPORT OF INJURY OR HARM TO THE PATIENT B.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532969 MCKESSON CARDIOLOGY MCKESSON CARDIOLOGY LLZ MCKESSON ISRAEL LTD. 13.1.1

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR