BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CXR4

    MDR report key: 3994779 · Received June 13, 2014

    Report

    Report Number
    8030405-2014-00004
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 22, 2014
    Manufacturer
    HITACHI MEDICAL CORP.,
    Product Code
    JAK
    PMA / PMN Number
    K040902
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SITE HAD REPORTED VERY INTERMITTENT COMMUNICATION ERRORS, CODE 0T04. THE TIME PERIOD OF THE REPORTS WERE FROM (B)(6) 2014, BUT THE NATURE OF THE PROBLEM MADE IT EXTREMELY DIFFICULT FOR OUR SERVICE PERSONNEL TO REPRODUCE. THE FREQUENCY BETWEEN ERROR REPORTS AVERAGED 6 DAYS. SOME COMPONENTS WERE REPLACED DURING THAT PERIOD, BUT THE ERROR CONTINUED TO OCCUR. THE CUSTOMER DID NOT ALLOW HITACHI SERVICE EXTENSIVE TROUBLESHOOTING UNTIL THE REPORT OF (B)(6) 2014 AFTER WE HAD DISCOVERED THAT THEY HAD PERFORMED THE REPEATED SCANS ON A PATIENT. AT THAT TIME WE INSISTED THAT THE SYSTEM BE CONSIDERED DOWN. DURING TROUBLESHOOTING LAST WEEK, THE SERVICE ENGINEER WAS ABLE TO REPRODUCE THE ERROR MORE OFTEN. AFTER THE SYSTEM'S X-RAY TUBE WAS REPLACED ON (B)(4) 2014, THE ERROR HAS NOT RE-OCCURRED. HITACHI BELIEVES NOISE THAT INTERRUPTED SYSTEM COMMUNICATIONS AND GENERATED THE ERROR.

    Description of Event or Problem · 1

    HITACHI MEDICAL SYSTEMS (B)(4) RECEIVED A REPORT FROM A U.S. CUSTOMER ON (B)(6) 2014. THEY HAD SCANNED A PATIENT ON (B)(6) 2014, WHERE THEY INDICATED THAT DUE TO A SCAN ERROR, THEY HAD RESTARTED THE EXAM 6 TIMES. THE ERROR OCCURRED ON THE FIRST 5 ATTEMPTS, THEN THE 6TH SCAN WAS SUCCESSFUL. THE ERROR HAD BEEN ONGOING, BUT (B)(4) WAS PREVIOUSLY UNAWARE THAT THE CUSTOMER REPEATED SCANS IN ORDER TO COMPLETE THE PATIENT EXAM. QUESTIONING THE CUSTOMER, THE SYSTEM HAD REPEATEDLY FAILED IN THE EARLY STAGES OF THE EXAM, WHICH CALLED FOR A TOTAL OF 40 IMAGES TO BE PRODUCED. THE CUSTOMER ESTIMATED THAT THE FAILURE OCCURRED AFTER 1 TO 2 IMAGES WERE PRODUCED FOR THE FIRST 5 ATTEMPTS. IN PREVIOUS CASES WHERE THE ERROR OCCURRED, THE SITE WAS ABLE TO RESET THE SYSTEM AND COMPLETE THE SCAN WITHOUT REPEATED ATTEMPTS. BASED ON THIS REPORT, (B)(4) ESTIMATES THAT THE PATIENT SCANNED ON (B)(6) 2014 RECEIVED ABOUT 25% MORE X-RAY DOSE THAN EXPECTED FOR THAT EXAM (2 IMAGES X 5 SCANS/40 IMAGES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351358 CXR4 SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK HITACHI MEDICAL CORP., CXR4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1