BEUDAMED
    FDA Adverse Event Death Summary report: N

    XPER FLEX CARDIO PHYSIOMONITORING SYSTEM

    MDR report key: 6421357 · Received March 21, 2017

    Report

    Report Number
    1051786-2017-00007
    Event Type
    Death
    Date Received
    March 21, 2017
    Date of Event
    March 4, 2017
    Report Date
    March 15, 2017
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MWI
    PMA / PMN Number
    K101571
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFORMATION CONCERNING THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION FOR THE ISSUE REPORTED CONCLUDES NO MALFUNCTION OF THE SYSTEM OCCURRED. THE CAUSE OF THE PROBLEM WAS ATTRIBUTED TO USER ERROR / TRAINING. THE ATTENDING PHILIPS FIELD SERVICE ENGINEER VISITED THE CUSTOMER'S SITE AND WAS UNABLE TO CONFIRM A DEVICE MALFUNCTION. AFTER DISCUSSING THIS INCIDENT WITH END USERS, IT WAS DETERMINED THAT AN ELECTRODE MAY HAVE BECOME DISCONNECTED DURING THE CASE, WHICH CAUSED THE ISSUE TO OCCUR. PHILIPS CLINICAL PERSONNEL ALSO MADE THE SAME CONCLUSION FOLLOWING REVIEW OF THE INFORMATION AVAILABLE FOR THIS CASE. THE FSE PROVIDED STAFF WITH TRAINING ON HOW TO BETTER APPLY ELECTRODES AND CLEAN THE SKIN. NO PARTS WERE REPLACED OR RETURNED TO PHILIPS IN ASSOCIATION WITH THIS COMPLAINT AND THE DEVICE REMAINS IN USE AT THE CUSTOMER'S SITE. THE ABSENCE OF FURTHER CALLS SUPPORTS THAT THE REPORTED PROBLEM WAS RESOLVED. NO FURTHER ACTION OR INVESTIGATION IS WARRANTED BASED ON THE AVAILABLE INFORMATION AT THE TIME OF COMPLAINT CLOSURE. IN THE EVENT ADDITIONAL INFORMATION IS RECEIVED, ANOTHER INVESTIGATION WILL BE OPENED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED INTERMITTENT ECG SIGNAL DISTURBANCES. THE CUSTOMER REPORTEDLY SHOCKED THE PATENT (TRIED TO RESUSCITATE A PATIENT WITH THE PALLETS) AS THEY THOUGHT THE QRS WAS LOW COMPARED TO THE ECG SIGNAL. THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204800 XPER FLEX CARDIO PHYSIOMONITORING SYSTEM PHYSIOMONITORING SYSTEM MANAGEMENT DEVICE MWI INVIVO CORPORATION 453564243591 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death