BEUDAMED
    FDA Adverse Event Death Summary report: N

    EEG-1200A

    MDR report key: 7520252 · Received May 16, 2018

    Report

    Report Number
    8030229-2018-00158
    Event Type
    Death
    Date Received
    May 16, 2018
    Date of Event
    April 17, 2018
    Report Date
    July 22, 2019
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    OLT
    UDI-DI
    04931921110904
    PMA / PMN Number
    K080546
    Removal / Correction Number
    NOT APPLICABLE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE: ON (B)(6) 2018, (B)(6) REPORTED THE PTZ CONTROLS WERE OFF THE SCREEN. SERVICE REQUESTED/PERFORMED: INFORMATION WAS PROVIDED TO THE CUSTOMER TO GET THE CONTROLS BACK ONTO THE SCREEN AND RESOLVE THE ISSUE. THERE WAS A REPORT OF A PATIENT DEATH WHILE CONNECTED TO THE MACHINE. THE CUSTOMER WAS CONTACTED MULTIPLE TIMES TO OBTAIN ADDITIONAL INFORMATION REGARDING THE INCIDENT. MISSING INFORMATION: INFORMATION REGARDING THE PATIENT INCIDENT IS MISSING DUE TO LACK OF CUSTOMER RESPONSE. INVESTIGATION RESULT: THE ROOT CAUSE OF THE PTZ ISSUE IS DUE TO USER ERROR/EDUCATION. THE CUSTOMER WAS NOT AWARE OF THE STEPS TO TAKE TO RETURN THE CONTROLS TO THE SCREEN. THE DEVICE WAS IN USE ON A PATIENT AND THERE WAS A REPORT OF PATIENT DEATH. HOWEVER, THERE WAS NO INFORMATION TO INDICATE THE PATIENT DEATH WAS DUE TO A DEVICE MALFUNCTION OR DEFICIENCY. THIS DEVICE IS USED FOR DIAGNOSTIC PURPOSES AND NOT MONITORING OF VITAL SIGNS. PER ATTACHED MDR DECISION TREE, THE PTZ ISSUE IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY. BASED ON THE GIVEN INFORMATION, THIS COMPLAINT RECORD CAN BE CONSIDERED LOW RISK AND WILL BE CLOSED AS NO FURTHER INVESTIGATION IS NEEDED AT THIS TIME. CORRECTED INFORMATION: DATE RECEIVED BY MANUFACTURER: SHOULD BE 04/17/2018 NOT 05/16/2018 AS LISTED ON MDR INITIAL REPORT ADDITIONAL INFORMATION: DATE OF THIS REPORT, SERIAL #, HEALTH PROFESSIONAL? OCCUPATION, DATE USER FACILITY/IMPORTER BECAME AWARE OF THE EVENT TYPE OF REPORT, APPROXIMATE AGE OF DEVICE, DATE REPORT SENT TO FDA, DATE REPORT SENT TO MANUFACTURER, DATE RECEIVED BY MANUFACTURER, TYPE OF REPORT, IF FOLLOW-UP, WHAT TYPE? ADDITIONAL INFORMATION , CORRECTION, DEVICE EVALUATED BY MANUFACTURER? DEVICE MANUFACTURE DATE, EVENT PROBLEM AND EVALUATION CODES, ADDITIONAL MANUFACTURER NARRATIVE. THE FOLLOWING FIELDS ARE NOT APPLICABLE (N/A) TO THIS REPORT: THE FOLLOWING FIELDS CONTAIN NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED: THE CUSTOMER DID NOT INITIALLY RESPOND TO FOLLOW UP REQUESTS. CONTACT WITH THE CUSTOMER WAS FINALLY MADE, HOWEVER, NO INFORMATION WAS PROVIDED. AGE AT TIME OF EVENT, DATE OF BIRTH, SEX, WEIGHT, ETHNICITY, RACE, RELEVANT TESTS/LABORATORY DATA, INCLUDING DATES, OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT A PATIENT HAD EXPIRED WHILE BEING CONNECTED TO OUR MACHINE.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT A PATIENT HAD EXPIRED WHILE BEING CONNECTED TO OUR MACHINE. NO MALFUNCTION OF THE EEG DEVICE WAS REPORTED. NIHON KOHDEN CONTINUES TO INVESTIGATE THE REPORTED EVENT. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT HAD EXPIRED WHILE BEING CONNECTED TO OUR MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361423 EEG-1200A NEUROFAX ELECTROENCEPHALOGRAPH OLT NIHON KOHDEN CORPORATION EEG-1200A NOT APPLICABLE 04931921110904

    Patients

    Seq Age Sex Outcome Treatment
    1 Death NOT APPLICABLE.