BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6201A

    MDR report key: 9050477 · Received September 13, 2019

    Report

    Report Number
    8030229-2019-00461
    Event Type
    Malfunction
    Date Received
    September 13, 2019
    Date of Event
    August 21, 2019
    Report Date
    November 9, 2020
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921114131
    PMA / PMN Number
    K102376
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: ON (B)(6) 2019, THE CUSTOMER AT (B)(6) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) (PU-621RA, SN: (B)(6) ) WOULD NOT POWER ON. THE CUSTOMER WAS ABLE TO VIEW CONTENT AFTER CONNECTING A DIFFERENT MONITOR. SERVICE REQUESTED/PERFORMED: EXCHANGE OF A/E000528; NKA REPAIR CENTER EVALUATION OF RETURNED CUSTOMER PART TOUCHSCREEN A/E000528, SN: (B)(6): PHYSICAL EVALUATION: NO PHYSICAL DAMAGE NOR FLUID INTRUSION NO DISPLAY PROBLEM WAS DUPLICATED. POSSIBLE MALFUNCTIONED PCB OR POWER SUPPLY. TESTED WITH KNOWN GOOD POWER SUPPLY, UNIT WAS FUNCTIONING AS INTENDED. THE UNIT WAS TESTED PER THE OPERATOR'S/SERVICE MANUAL AND WAS COMPLETED 24 HOURS OF EXTENDED TESTING AND OPERATES TO MANUFACTURER'S SPECIFICATIONS. INVESTIGATION SUMMARY: THE ROOT CAUSE IS NOT KNOWN AS EVALUATION OF THE COMPLAINT UNIT DID NOT IDENTIFY A NON-CONFORMANCE. POTENTIAL CAUSES INCLUDE CUSTOMER SET UP/USE OF ACCESSORIES. FROM THE INFORMATION AVAILABLE, THE REPORTED ISSUE IS NOT SUSPECTED TO INVOLVE AN NK PRODUCT MALFUNCTION. INVESTIGATION DETERMINED THE ISSUE POSES MEDIUM RISK. EVALUATION OF THE COMPLAINT UNIT AT NKA DID NOT IDENTIFY A NON-CONFORMANCE; NO MALFUNCTION OF AN NK PRODUCT IS SUSPECTED AT THIS TIME. THE REPORTED ISSUE DOES NOT WARRANT FURTHER INVESTIGATION THROUGH THE CAPA PROCESS. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE WAS USED IN CONJUNCTION WITH THE CNS AND WAS THE DEVICE THAT EXPERIENCED THE FAILURE: TOUCHSCREEN: MODEL #: A/E000528 SERIAL #: (B)(6).

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) JUST STARTED FLASHING OFF AND ON. THEN IT WOULD NOT TURN ON, AND THIS HAPPENED RATHER QUICKLY. THEY BELIEVE THAT THEY WERE MONITORING PATIENTS AS THIS IS A VERY BUSY HOSPITAL AND BELIEVE THAT THEY WOULD HAVE BEEN MONITORING BEDSIDE MONITORS. NO PATIENT HARM WAS REPORTED.

    Additional Manufacturer Narrative · 1

    THE BIOMEDICAL ENGINEER REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) JUST STARTED FLASHING OFF AND ON. THEN IT WOULD NOT TURN ON, AND THIS HAPPENED RATHER QUICKLY. THEY BELIEVE THAT THEY WERE MONITORING PATIENTS AS THIS IS A VERY BUSY HOSPITAL AND BELIEVE THAT THEY WOULD HAVE BEEN MONITORING BEDSIDE MONITORS. THEY WILL BE PROVIDED WITH AN EXCHANGED MONITOR FOR THE CNS TO RESOLVE THE ISSUE. NO PATIENT HARM WAS 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: CONCOMITANT MEDICAL PRODUCTS.

    Description of Event or Problem · 1

    THE BIOMEDICAL ENGINEER REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) JUST STARTED FLASHING OFF AND ON. THEN IT WOULD NOT TURN ON, AND THIS HAPPENED RATHER QUICKLY. THEY BELIEVE THAT THEY WERE MONITORING PATIENTS AS THIS IS A VERY BUSY HOSPITAL AND BELIEVE THAT THEY WOULD HAVE BEEN MONITORING BEDSIDE MONITORS. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821423 CNS-6201A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6201A NA 04931921114131

    Patients

    Seq Age Sex Outcome Treatment
    1 TOUCHSCREEN