BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-9700A

    MDR report key: 7481787 · Received May 2, 2018

    Report

    Report Number
    8030229-2018-00140
    Event Type
    Malfunction
    Date Received
    May 2, 2018
    Date of Event
    April 2, 2018
    Report Date
    January 15, 2020
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921000663
    PMA / PMN Number
    K023475
    Removal / Correction Number
    NOT APPLICABLE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF THE COMPLAINT: ON (B)(6) 2018, CUSTOMER AT PHELPS COUNTY REGIONAL MEDICAL CENTER REPORTED VITALS NOT POPULATING ON CGS-9100G-S. THE DETAILS OF THE DEVICE WITH THE ISSUE HAVE NOT BEEN REPORTED AT THE TIME OF COMPLAINT, SUCH REPORTS ARE ADDRESSED UNDER CAPA-18-033. SERVICE REQUESTED: ASSISTANCE IN TROUBLESHOOTING. SERVICE PERFORMED: CUSTOMER REPORTED ISSUE RELATED TO UNIT FOR NOT PULLING VITALS OVER, LOOSING AND DELETING OF VITALS, PULLING DOCTORS NAME WHEN THEY HAVEN'T BEEN PUT IN BY STAFF. ALSO, UNIT DID NOT ALARM AT THE TIME OF VTACH ON A PATIENT IN ROOM 2. NKTS REQUESTED HL7 FOR ASSISTANCE IN TROUBLESHOOTING THE ISSUE. HL7 TEAM CALLED BACK TO THE CUSTOMER REQUESTING FURTHER DETAILS ON THE ISSUES RELATED TO REPORTED INCIDENTS. CUSTOMER REPORTED THAT ONE OF THE ISSUE WAS SELF-RESOLVED, HOWEVER THE CUSTOMER WILL CALL BACK WITH CROSS VERIFYING THE DETAILS FROM STAFF. CUSTOMER STOPPED COMMUNICATING AFTER MULTIPLE ATTEMPTS. THE ROOT CAUSE OF THE ISSUE COULD NOT BE IDENTIFIED AS CUSTOMER STOPPED COMMUNICATING AFTER MULTIPLE ATTEMPTS. INVESTIGATION RESULT(S): ROOT CAUSE OF THE ISSUE COULD NOT BE IDENTIFIED AS CUSTOMER STOPPED COMMUNICATING AFTER MULTIPLE ATTEMPTS. REVIEW OF PRODUCT FAMILY HISTORY FOUND NO PREVIOUSLY REPORTED SIMILAR ISSUES. NO FURTHER DETAILS ON THE DEVICE HISTORY AS WELL AS PRODUCT FAMILY HISTORY COULD BE COLLECTED DUE TO UNAVAILABILITY OF DEVICE INFORMATION PROVIDED BY THE CUSTOMER.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER REPORTED THAT THE VITAL SIGNS WERE NOT POPULATING; SOME WERE BEING DELETED OR LOST. THERE WAS ALSO A REPORT OF A PATIENT THAT HAD A RUN OF VTAC AND THE MONITOR DID NOT ALARM.

    Additional Manufacturer Narrative · 1

    THE BIOMEDICAL ENGINEER REPORTED THAT THE VITAL SIGNS WERE NOT POPULATING; SOME WERE BEING DELETED OR LOST. THERE WAS ALSO A REPORT OF A PATIENT THAT HAD A RUN OF VTAC AND THE MONITOR DID NOT ALARM. NIHON KOHDEN CONTINUES TO INVESTIGATE THE REPORTED EVENT. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE. NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 1

    THE BIOMEDICAL ENGINEER REPORTED THAT THE VITAL SIGNS WERE NOT POPULATING; SOME WERE BEING DELETED OR LOST. THERE WAS ALSO A REPORT OF A PATIENT THAT HAD A RUN OF VTAC AND THE MONITOR DID NOT ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322171 CNS-9700A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-9700A 04931921000663

    Patients

    Seq Age Sex Outcome Treatment
    1