BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EEG-1200A

    MDR report key: 7598830 · Received June 13, 2018

    Report

    Report Number
    8030229-2018-00207
    Event Type
    Malfunction
    Date Received
    June 13, 2018
    Date of Event
    May 15, 2018
    Report Date
    February 7, 2020
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    OLT
    UDI-DI
    04931921110904
    PMA / PMN Number
    K080546
    Removal / Correction Number
    NOT APPLICABLE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT INFORMATION: ON 05/15/2018, CUSTOMER AT (B)(6) MEDICAL CENTER REPORTED UPS STARTED SMOKING DURING EEG EXAMINATION. THE SERIAL# OF UPS WAS (B)(6) WITH PRODUCT ID: A/ABCE422-11MED SERVICE REQUESTED: ASSISTANCE IN TROUBLESHOOTING. SERVICE PERFORMED: CUSTOMER REPORTS THAT DURING AN EEG, THE UPS STARTED SMOKING AND THEN THEY HAD TO CALL A CODE ORANGE AND EVACUATE THE ROOM. NKTS REQUESTED CUSTOMER TO SEND UPS UNIT IN TO REPAIR CENTER AND ESCALATED THE ISSUE TO QA FOR FURTHER INVESTIGATION. INVESTIGATION RESULT: ROOT CAUSE OF THE ISSUE AS PER THE MANUFACTURER FINDINGS WAS DEEPLY DISCHARGED BATTERIES (BATTERY CONNECTED WITHOUT AC POWER FOR AN EXTENDED PERIOD OF TIME). WHEN POWER WAS APPLIED TO THE UPM, THE BATTERIES WERE IN A DEFECTIVE STATE AND SWELLED. THE UNIT WILL CHARGE THE BATTERY THAT IS WEAKENED, THIS LEADS TO FAILURE IN THE BATTERY, CAUSING THE BATTERY TO EXCEED BATTERY DESIGN LIMITS CAUSING EXPANSION AND VENTING. ACCORDING TO THE TABLE IN QUALITY COMPLAINT INVESTIGATIONS WORK INSTRUCTION, WITH DOCUMENT ID: SOP06-075, THE RISK PRIORITY OF THE ISSUE IS CATEGORIZED AS: MEDIUM. CORRECTIVE AND PREVENTATIVE ACTIONS TAKEN: MANUFACTURERS HAVE UPDATED FIRMWARE TO DETECT SEVERELY DEPLETED BATTERIES. THE USER WILL BE ALERTED VISUALLY VIA THE FRONT PANEL DISPLAY. ALL ICONS ON THE DISPLAY WILL CYCLE ON AND OFF. THE DISPLAY WILL CONTINUE UNTIL THE BATTERY IS DISCONNECTED OR AC REMOVED. A FIELD BULLETIN HAS BEEN ISSUED DESCRIBING WHAT STEPS NEED TO BE TAKEN. D11 & C2: THE EEG THAT WAS BEING USED WITH THE UPS HAD NO ISSUE. THE ISSUE IS WITH THE UPS THAT WAS BEING USED IN CONJUNCTION WITH THE EEG. MODEL: A/ABCE422-11MED. SERIAL: (B)(6).

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER REPORTED THAT THE UPS STARTED SMOKING DURING THE USE OF THE EEG-1200A.

    Additional Manufacturer Narrative · 1

    THE BIOMEDICAL ENGINEER REPORTED THAT THE UPS STARTED SMOKING DURING THE USE OF THE EEG-1200A. THE UNIT WAS IN USE ON PATIENTS AT THE TIME, BUT NO PATIENT HARM WAS REPORTED. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE BIOMEDICAL ENGINEER REPORTED THAT THE UPS STARTED SMOKING DURING THE USE OF THE EEG-1200A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439263 EEG-1200A NEUROFAX ELECTROENCEPHALOGRAPH OLT NIHON KOHDEN CORPORATION EEG-1200A NOT APPLICABLE 04931921110904

    Patients

    Seq Age Sex Outcome Treatment
    1 UPS