BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GF-210RA

    MDR report key: 12013864 · Received June 16, 2021

    Report

    Report Number
    2080783-2021-00345
    Event Type
    Malfunction
    Date Received
    June 16, 2021
    Date of Event
    May 19, 2021
    Report Date
    June 16, 2021
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    CCK
    UDI-DI
    04931921106891
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT DURING A LONG CASE, THE MULTIGAS UNIT LOSES READINGS INTERMITTENTLY. ACCORDING TO THE CUSTOMER, THE UNIT WORKS FINE IN SHORT TEMS, BUT IN LONG CASE THE UNIT PRESENTS WITH THE REPORTED ISSUE. THE CUSTOMER WILL SEND IN THE UNIT FOR EXCHANGE. THERE WAS NO PATIENT INJURY 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. THE FOLLOWING FIELDS CONTAIN NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED: ATTEMPT # 1: 06/02/2021 EMAILED THE CUSTOMER VIA MICROSOFT (B)(6) FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 2: 06/03/2021 EMAILED THE CUSTOMER VIA MICROSOFT (B)(6) FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 3 06/09/2021 EMAILED THE CUSTOMER VIA MICROSOFT (B)(6) FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 1: 06/02/2021 EMAILED THE CUSTOMER VIA MICROSOFT (B)(6) FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 2: 06/03/2021 EMAILED THE CUSTOMER VIA MICROSOFT (B)(6) FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 3 06/09/2021 EMAILED THE CUSTOMER VIA MICROSOFT (B)(6) FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 1: 06/02/2021 EMAILED THE CUSTOMER VIA MICROSOFT (B)(6) FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 2: 06/03/2021 EMAILED THE CUSTOMER VIA MICROSOFT (B)(6) FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 3 06/09/2021 EMAILED THE CUSTOMER VIA MICROSOFT (B)(6) FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A LONG CASE THE MULTIGAS UNIT LOSES READINGS INTERMITTENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905527 GF-210RA MULTI-GAS UNIT CCK NIHON KOHDEN CORPORATION GF-210RA NA 04931921106891

    Patients

    Seq Age Sex Outcome Treatment
    1