BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6201A

    MDR report key: 7806882 · Received August 22, 2018

    Report

    Report Number
    8030229-2018-00334
    Event Type
    Malfunction
    Date Received
    August 22, 2018
    Date of Event
    July 23, 2018
    Report Date
    August 22, 2018
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921114131
    PMA / PMN Number
    K102376
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: F7: TYPE OF REPORT. G7: TYPE OF REPORT. H2: IF FOLLOW-UP, WHAT TYPE (CORRECTION OR ADDITIONAL OR BOTH). H6: EVEN PROBLEM AND EVALUATION CODES. ADDITIONAL INFORMATION: H10: MANUFACTURE NARRATIVE: DETAILS OF THE COMPLAINT: ON (B)(6) 2018, (B)(6) MEDICAL CENTER REPORTED THE CNS MONITOR LOCATED INSIDE THE PATIENT ROOM WAS NOT RESPONDING AND WOULD NOT POWER OFF. THERE WERE ON UPS AND THE POWER WAS OUT. THERE WERE 3 MONITORS AND THEY WERE CONNECTED TO A LAN NETWORK. SERVICE REQUESTED: TROUBLESHOOTING/ASSISTANCE SERVICE PERFORMED: THE POWER CORD CONNECTING THE NONWORKING MONITOR TO THE OUTLET WAS FOUND TO NOT BE PLUGGED IN. MISSING INFORMATION/REQUIRED INFORMATION: THE DEVICE INFORMATION ASSOCIATED WITH THE COMPLAINT FILE IS NOT ENTERED IN THE "PRODUCT" FIELD. THIS IS A KNOWN ISSUE AND IS ADDRESSED IN CAPA 18-033. INVESTIGATION OF THE COMPLAINT WILL CONTINUE WITHOUT THE PRODUCT INFORMATION. INVESTIGATION RESULT: THE ROOT CAUSE IS DETERMINED TO BE USER ERROR. THE CNS WAS NOT RESPONDING DUE TO NOT BEING PLUGGED IN. THE ISSUE WAS RESOLVED ONCE THIS WAS CORRECTED. THE DEVICE WAS IN USE WITH A PATIENT AND THERE WAS NO REPORTED HARM. THE DEVICE WAS OPERATING WITHIN SPECIFICATIONS. THERE IS NO INDICATION OF IMPROPER/INADEQUATE DEVICE DESIGN.

    Additional Manufacturer Narrative · 1

    WHEN THEY TRACED THE POWER CORD FROM THE DEVICE TO THE WALL OUTLET, IT WAS FOUND TO BE UNPLUGGED. PLUGGING THE UNIT BACK IN RESOLVED THE ISSUE. NO PATIENT HARM WAS REPORTED. NIHON KOHDEN TECHNICAL SERVICES AGENTS MADE 3 ATTEMPTS TO GET THE MODEL INFORMATION AND WAS NOT SUCCESSFUL. 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 THE CENTRAL NURSE'S STATION (CNS) WAS NOT RESPONDING AND WOULD NOT TURN OFF AFTER A POWER OUTAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648286 CNS-6201A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6201A 04931921114131

    Patients

    Seq Age Sex Outcome Treatment
    1