BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6201A

    MDR report key: 9759627 · Received February 26, 2020

    Report

    Report Number
    8030229-2020-00119
    Event Type
    Malfunction
    Date Received
    February 26, 2020
    Date of Event
    February 13, 2020
    Report Date
    February 1, 2023
    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
    NE, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE CUSTOMER REPORTED THAT THE PRIMARY DISPLAY SCREEN ON THE CENTRAL NURSE'S STATION (CNS) WAS NOT WORKING. TECHNICAL SUPPORT (TS) ADVISED THE CUSTOMER TO SWAP THE CABLES FROM THE SECONDARY DISPLAY TO CONFIGURE THE UNIT. THE CUSTOMER DID THIS, BUT LATER REPORTED THAT THEY NEEDED TROUBLESHOOTING WITH A FAILED RAID HARD DRIVE. NO PATIENT HARM OR INJURY WAS REPORTED. INVESTIGATION SUMMARY: THE COMPLAINT UNIT WAS RETURNED AND EVALUATED BY NIHON KOHDEN REPAIR CENTER (NK RC). N NK RC WAS ABLE TO OBSERVE THE REPORTED ISSUE. NK RC IDENTIFIED THAT THE POWER SUPPLY OF THE DEVICE HAD MALFUNCTIONED. AFTER THE DEVICE WAS REPAIRED, IT PASSED EXTENDED TESTING AND WAS PERFORMING WITHIN SPECIFICATIONS. A REVIEW OF THE HISTORY OF THE SERIAL NUMBER IDENTIFIED NO FURTHER OCCURRENCES OF THE ISSUE. BASED ON THE AVAILABLE INFORMATION, THE MOST PROBABLE CAUSE OF THE ISSUE IS A POWER SUPPLY FAILURE. POTENTIAL CAUSES OF A POWER SUPPLY FAILURE ARE VIBRATION OR IMPACT ON THE COMPONENT, STATIC ELECTRICITY, ELECTROMAGNETIC INTERFERENCE, DETERIORATION OF THE COMPONENT AND FLUCTUATION OR DISTURBANCE IN VOLTAGE (I.E., POWER SURGES AND POWER OUTAGES).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE PRIMARY DISPLAY SCREEN ON THE CENTRAL NURSE'S STATION (CNS) WAS NOT WORKING.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THEIR CENTRAL NURSE'S STATION (CNS) PRIMARY SCREEN IS NOT WORKING. NK TS ADVISED THE CUSTOMER TO SWAP THE CABLES FROM THE SECONDARY DISPLAY IN ORDER TO CONFIGURE THE UNIT. THE CUSTOMER COMPLIED, BUT LATER REPORTED THAT NOW THEY NEED TROUBLESHOOTING WITH A FAILED RAID HARM DRIVE. THE CUSTOMER WILL BE SENDING THIS UNIT IN FOR AN EXCHANGE. NO HARM OR 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 FIELD CONTAINS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED: CONCOMITANT MEDICAL PRODUCTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR CENTRAL NURSE'S STATION (CNS) PRIMARY SCREEN IS NOT WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217306 CNS-6201A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6201A NA 04931921114131

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown