BEUDAMED
    FDA Adverse Event Death Summary report: N

    XPER IM PHYSIOMONITORING 5

    MDR report key: 1908078 · Received November 11, 2010

    Report

    Report Number
    1039368-2010-00002
    Event Type
    Death
    Date Received
    November 11, 2010
    Date of Event
    October 6, 2010
    Report Date
    November 11, 2010
    Manufacturer
    WITT BIOMEDICAL CORPORATION, A WHOLLY OWNED SUBSIDIARY OF PHILIPS HOLDING USA IN
    Product Code
    MWI
    PMA / PMN Number
    K063840
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT VA MEDICAL CENTER-(B)(6) IMPLEMENTED A NEW NETWORK SECURITY PROTOCOL ON (B)(6) 2010. THIS CAUSED A BLOCK ON THE COMMUNICATIONS PORT FOR PHILIPS XCELERA CONNECT AND THE XPER CONNECT DEVICES. THE ECHO STUDY PERFORMED ON (B)(6) 2010 WAS COLLECTED ON THE XCELERA WORK STATION AND SHOULD HAVE BEEN MOVED TO THE XCELERA CONNECT STATION FOR ARCHIVING AND FURTHER MOVEMENT TO THE XPER CONNECT SYSTEM. XPER CONNECT ACTS AS A PASS THROUGH FOR THE DATA TO THE HOSPITAL EMR SYSTEM. THE HOSPITAL CONTACTED PHILIPS CUSTOMER SERVICE ON (B)(6) 2010 FOR ASSISTANCE, AS THEY NOTICED THAT THE FEED WAS NOT WORKING PROPERLY. AT THAT TIME, THE XCELERA CONNECT PORT WAS RE-CONFIGURED AND THE DEVICE REBOOTED TO REINSTATE THE CONNECTION. NO ACTIONS WERE TAKEN TO RE-CONFIGURE THE XPER CONNECT DEVICE TO REESTABLISH THE CONNECTION BY THE ACCOUNT. THE XPER CONNECT DEVICE WAS WAITING FOR ACCESS TO THE EMR SYSTEM TO DOWNLOAD PENDING TRANSMISSION. THE ACCESS PERMISSION WAS GRANTED ON 10/18/2010 AND THE FILES DOWNLOADED WITHOUT ANY ISSUE. THE XPER CONNECT DEVICE FUNCTIONED AS INTENDED. THE CONNECTION WAS BLOCKED DUE TO NEW NETWORK SECURITY PROTOCOL IMPLEMENTED BY THE HOSPITAL AND THE SYSTEM COULD NOT REESTABLISH CONNECTION FOR THE TRANSMITTAL OF RECORDS. IT SHOULD BE NOTED THAT ECHO STUDY WAS ALWAYS AVAILABLE TO THE PHYSICIAN FOR VIEWING ON THE REVIEW STATION IN THE CATHLAB BY LAUNCHING XCELERA DIRECTLY. THE XPER INFORMATION MANAGEMENT IFU WAS REVIEWED AND INSTRUCTIONS ON HOW TO CHECK THE XPER CONNECT SYSTEM STATUS ARE PROVIDED "XPER CONNECT SETUP CHECKS" TO VERIFY PROPER FUNCTIONING OF THE DATA FEED. THIS CHECK COULD HAVE BEEN PERFORMED AFTER THE SECURITY PROTOCOL UPDATE.

    Description of Event or Problem · 1

    ON 10/18/2010, THE CUSTOMER INFORMED A COMPANY REPRESENTATIVE AT THE PHILIPS RESPONSE CENTER OF THE FOLLOWING EVENT: THE ECHO REPORT WAS NOT AVAILABLE IN THE PATIENT ELECTRONIC MEDICAL RECORD BECAUSE THE ECHO REPORT DID NOT CROSS OVER TO HOSPITAL NETWORK. CUSTOMER ALLEGES THIS WAS A CONTRIBUTING FACTOR TO A PATIENT DEATH BECAUSE DEATH MAY NOT HAVE HAPPENED IF PHYSICIAN WOULD HAVE HAD THE REPORT AVAILABLE TO HIM; THE PHYSICIAN WOULD HAVE NOT SCHEDULED THE HEART CATH STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XPER IM PHYSIOMONITORING 5 XPER IM INTERFACE BROKER MWI WITT BIOMEDICAL CORPORATION, A WHOLLY OWNED SUBSIDIARY OF PHILIPS HOLDING USA IN 4522 300 35023

    Patients

    Seq Age Sex Outcome Treatment
    1 Death