BEUDAMED
    FDA Adverse Event Death Summary report: N

    CORE MOBILE

    MDR report key: 6546450 · Received May 4, 2017

    Report

    Report Number
    2939520-2017-00046
    Event Type
    Death
    Date Received
    May 4, 2017
    Date of Event
    March 31, 2017
    Report Date
    April 4, 2017
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    IYO
    PMA / PMN Number
    K153369
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. ADDITIONAL INFORMATION OBTAINED INDICATED DURING THE PROCEDURE THE PATIENT EXPERIENCED A MAJOR CARDIAC ADVERSE EVENT (MACE) AND RESUSCITATION WAS PERFORMED. TWO DAYS LATER, THE PATIENT DIED IN THE INTENSIVE THERAPY UNIT ON SUNDAY (B)(6) 2017. THE PHYSICIAN SAID THE MANUFACTURER'S DEVICES WERE NOT A PROBLEM, AND IT DID NOT CAUSE TO INJURY TO THE PATIENT; THE PATIENT WAS COMPLICATED BY HIS CLINICAL CONDITION. THE DISTRIBUTOR NOTED THE CUSTOMER REMOVED THE VIDEO LOOPS AND TRANSFERRED THE PATIENT IMAGES TO THE PACS. THEY THEN DELETED THE COPY OF THE ORIGINAL PATIENT CASE THAT THEY CREATED. NO TESTS/LABORATORY DATA WAS AVAILABLE. NO INFORMATION WAS AVAILABLE. THE LOT # AND EXPIRATION DATE ARE NOT APPLICABLE TO THIS DEVICE. THE UDI NUMBER IS NOT APPLICABLE TO THIS DEVICE AS IT WAS MANUFACTURED PRIOR TO 09-24-2016. THE IMPLANT OR EXPLANT DATES ARE NOT APPLICABLE TO THIS DEVICE. DEVICE IS AVAILABLE FOR EVALUATION AT THE FACILITY. IT WAS NOT RETURNED FOR EVALUATION. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE EVENT LOGS WERE REVIEWED. IT WAS DETERMINED THAT THE USER DELETED TWO (2) CASES AFTER UNSUCCESSFUL ARCHIVAL OF CASES TO THE DICOM/PACS SERVER. THE USER ATTEMPTED TO ARCHIVE THE FIRST CASE TRANSFERRED TO THE DICOM, WHICH WAS ABORTED DUE TO A COMMUNICATION ERROR WITH THE DICOM/ PACS NETWORK. ACCORDING TO THE LOG FILE, THE CASE WAS DELETED BY THE USER AFTER 40 SECONDS. THE USER ATTEMPTED TO ARCHIVE A SECOND CASE TO THE DICOM SERVER, WHICH ALSO WAS ABORTED DUE TO FAILURE TO CONNECT TO THE REMOTE HOST. THIS CASE ALSO WAS DELETED BY THE USER AFTER 2 HOURS WITHOUT ARCHIVAL. THE SYSTEM WORKED AS INTENDED THROUGHOUT THE PROCESS. HOWEVER, THE USER DELETED THE PATIENT CASE RECORD WITHOUT SAVING THE DATA AFTER ARCHIVAL ATTEMPTS FAILED. THE ESTABLISHED WORKFLOW LIST IN THE OPERATOR'S MANUAL WAS NOT FOLLOWED TO ARCHIVE AN IVUS CASE. PER THE OPERATOR'S MANUAL FOR THIS DEVICE, CHAPTER 11 ENDING AN IVUS CASE: PAGE 87, OVERVIEW, INSTRUCTS ENDING A CASE IS EQUIVALENT TO SAVING THE CASE TO THE SYSTEM'S HARD DRIVE. ALTERNATIVELY, YOU MAY CHOOSE TO DELETE THE CASE. PAGE 87, ENDING A CASE, 3) CLICK OK WHEN YOU ARE READY TO END THIS CASE. THE CASE IS SAVED TO THE HARD DRIVE AND APPEARS IN THE LIST BOX WITH CASE TYPE ORIGINAL. NOTE 1: ALL THE CASES ON THE HARD DRIVE APPEAR IN THE LIST BOX. NOTE 2: ONLY 20 CASES ARE ALLOWED ON THE SYSTEM'S HARD DRIVE AT ONE TIME. PAGE 88, DELETING A CASE, 1) SELECT THE CASE IN THE LIST BOX THAT YOU WANT TO DELETE. THE CASE IS HIGHLIGHTED. 2) PRESS "DELETE CASE." A MESSAGE DISPLAYS, PROMPTING THE USER TO DELETE THE SPECIFIC CASE. THE USER CAN CLICK ON THE "DO NOT DISPLAY AGAIN" OPTION TO PREVENT THIS MESSAGE FROM REDISPLAYING. CHAPTER 14 RETRIEVING AND DELETING AN IVUS CASE: PAGE 96, DELETING A CASE, INSTRUCTS TO "ARCHIVE PATIENT CASES BEFORE DELETING THEM. OTHERWISE, CASE DATA WILL BE LOST UPON DELETION. CHAPTER 17 MAINTENANCE: PAGE 111, MAINTENANCE FREQUENCY, INSTRUCTS TO ARCHIVE PATIENT CASES DAILY AS USED. A REVIEW OF COMPLAINT CASES SUBMITTED FOR THIS ASSET WAS PERFORMED AND NO OTHER SIMILAR COMPLAINTS WERE REPORTED ON THIS ASSET FOR THIS FAILURE. THIS COMPLAINT WILL BE MONITORED AS PART OF COMPLAINT DATA ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED AFTER FINISHING A STUDY, THE SYSTEM "DELETED" THE PATIENT INFO. THE PATIENT DIED TWO DAYS AFTER IN THE ICU. THE EXPIRATION WAS NOT RELATED TO THE MANUFACTURER'S DEVICE. THIS EVENT IS BEING REPORTED BECAUSE THE PATIENT EXPIRED. THIS SUBMISSION IS FOR THE SYSTEM USED DURING THE PROCEDURE. A SECOND SUBMISSION IS BEING SUBMITTED UNDER MDR 2939520-2017-00047 FOR THE CATHETER USED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327405 CORE MOBILE SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO VOLCANO CORPORATION CORE MOBILE - 797002

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death