BEUDAMED
    FDA Adverse Event Other Summary report: N

    ECARDIO

    MDR report key: 3057309 · Received April 9, 2013

    Report

    Report Number
    MW5029728
    Event Type
    Other
    Date Received
    April 9, 2013
    Date of Event
    January 11, 2013
    Report Date
    March 30, 2013
    Manufacturer
    ECARDIO
    Product Code
    DRG
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    THE DEVICE'S LCD SCREEN INDICATES IT IS "MONITORING" EVEN AFTER ONE OF THE LEADS BECOMES DETACHED FROM THE PT. WHEN A LEAD BECOMES DETACHED, ACTUAL MONITORING CEASES, BUT THERE IS NO AUDIBLE OR OTHER WARNING THAT THE SIGNAL HAS BEEN LOST. MEANWHILE, THE SCREEN CONTINUES FLASHING ITS HAPPY "MONITORING" MESSAGE WITHOUT INTERRUPTION. THE PT IS LEFT UNAWARE, PERHAPS FOR HOURS, THAT HIS OR HER HEARTBEAT IS NOT BEING MONITORED, RESULTING IN A FALSE SENSE OF PERSONAL SECURITY AND THE UNRECOGNIZED LOSS OF CRITICAL DIAGNOSTIC DATA. WHEN I ASKED LABORATORY STAFF MEMBERS AT ECARDIO ((B)(4)) WHY THE DEVICE CLAIMS TO BE MONITORING WHEN IT IS NOT ATTACHED TO THE PT, AND WHY NO AUDIBLE WARNING IS PRODUCED WHEN IT BECOMES DISCONNECTED, THEY SAID "DETECTION OF LEAD LOSS IS NOT A PARAMETER FOR THE SOFTWARE." WHEN I TOLD A LAB MANAGER THAT I THOUGHT IT WAS "CRAZY" FOR THE DEVICE TO WORK THAT WAY, THERE WAS NO DISAGREEMENT ON THEIR PART; THEIR REPLY WAS ONLY THAT THE LAB HAS NO CONTROL OVER SOFTWARE DEVELOPMENT. IN SUMMARY, A MEDICAL DEVICE THAT CLAIMS, PER IT'S BROCHURE, TO "AUTOMATICALLY DETECT, CAPTURE AND SEND" REPORTS OF ABNORMAL HEART RHYTHMS NEEDS TO BE ABLE TO DETECT AND WARN THAT IT HAS ITSELF BECOME DISCONNECTED FROM THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144670 ECARDIO CARDIAC EVENT MONITOR DRG ECARDIO ER920W

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR