BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6201A

    MDR report key: 7764790 · Received August 8, 2018

    Report

    Report Number
    8030229-2018-00296
    Event Type
    Malfunction
    Date Received
    August 8, 2018
    Date of Event
    July 10, 2018
    Report Date
    January 23, 2020
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921114131
    PMA / PMN Number
    K102376
    Removal / Correction Number
    NOT APPLICABLE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF THE COMPLAINT NKA INSTALLER REPORTED THE CUSTOMER'S CNS (PU-621RA SN: (B)(6)) WAS NOT RESPONDING TO AUDIO. DIFFERENT UNITS AND CABLES WERE TRIED, BUT AUDIO WAS STILL NOT RESPONDING. THIS WAS AN OUT OF BOX FAILURE (OBF). SERVICE REQUESTED/PERFORMED EXCHANGE OF A/E000528 (24" TOUCH SCREEN) INVESTIGATION RESULT THE LCD DISPLAY FOR THE CNS IS MANUFACTURED BY ELO TOUCH SYSTEMS. EVALUATION OF THE ELO DISPLAY AT NKA CONFIRMED THE UNIT HAD NO AUDIO, AND THE UNIT WAS TO BE RETURNED TO THE MANUFACTURER. REVIEW OF THE CNS C4C HISTORY FOUND NO FURTHER ISSUES REPORTED WITH THE AUDIO AFTER EXCHANGE OF THE ELO TOUCH SCREEN DISPLAY. REVIEW OF COMPLAINTS FOUND ONE SIMILARLY REPORTED CASE: NOTIFICATION 300185050 (TICKET 70459) REPORTED AT (B)(6) ON (B)(6) IN WHICH NK INSTALLER REPORTED THE CNS AUDIO WAS NOT WORKING. THE INSTALLER LATER REPORTED THAT HE WAS ABLE TO FIX THE UNIT AND NO LONGER NEEDED AN EXCHANGE. AS THE ISSUE WAS ABLE TO BE RESOLVED ONSITE, THIS IS NOT SUSPECTED TO BE RELATED TO THE CURRENT ISSUE. AS NKA IS NOT THE MANUFACTURER OF THE ELO DISPLAY, AND THIS APPEARS TO BE AN ISOLATED INCIDENT, THE ROOT CAUSE COULD NOT BE DETERMINED. AS THE OBF WAS DETECTED DURING INSTALLATION OF THE CNS, THERE IS NO PATIENT IMPACT. INVESTIGATION CONCLUSION AS NKA IS NOT THE MANUFACTURER OF THE ELO DISPLAY, AND THIS APPEARS TO BE AN ISOLATED INCIDENT, THE ROOT CAUSE COULD NOT BE DETERMINED. AS THE OBF WAS DETECTED DURING INSTALLATION OF THE CNS, THERE IS NO PATIENT IMPACT. CORRECTION: F9. APPROXIMATE AGE OF DEVICE: INCORRECTLY CALCUATED. E2. ORIGINALLY SELECTED NO FOR HEALTH PROFESSIOANL. SHOULD BE CHECKED YES ADDITIONAL INFORMATION: B4. DATE OF THIS REPORT E3. OCCUPATION F6. DATE USER FACILITY/IMPORTER BECAME AWARE OF THE EVENT F7. TYPE OF REPORT F11. DATE REPORT SENT TO FDA F13. DATE REPORT SENT TO MANUFACTURER G4. DATE RECEIVED BY MANUFACTURER G7. TYPE OF REPORT H2. IF FOLLOW-UP, WHAT TYPE? CORRECTION ADDITIONAL INFORMATION DEVICE EVALUATION H3. DEVICE EVALUATED BY MANUFACTURER? H6. EVENT PROBLEM AND EVALUATION CODES H10. ADDITIONAL MANUFACTURER NARRATIVE

    Description of Event or Problem · 0

    THE NIHON KOHDEN INSTALLER REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) HAD NO AUDIO OUTPUT, SO NO ALARMS WOULD SOUND.

    Additional Manufacturer Narrative · 1

    THE NIHON KOHDEN INSTALLER REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) HAD NO AUDIO OUTPUT, SO NO ALARMS WOULD SOUND. THIS WAS FOUND AT INSTALL AND NO PATIENT INVOLVEMENT OCCURRED. THE INSTALLER WILL BE PROVIDED WITH A REPLACEMENT UNIT.

    Description of Event or Problem · 1

    THE NIHON KOHDEN INSTALLER REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) HAD NO AUDIO OUTPUT, SO NO ALARMS WOULD SOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603057 CNS-6201A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6201A NOT APPLICABLE 04931921114131

    Patients

    Seq Age Sex Outcome Treatment
    1