BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6201A

    MDR report key: 9690653 · Received February 10, 2020

    Report

    Report Number
    8030229-2020-00070
    Event Type
    Malfunction
    Date Received
    February 10, 2020
    Date of Event
    January 26, 2020
    Report Date
    April 17, 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
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT INFORMATION: ON 01/26/2020, CUSTOMER AT CAPITAL HEALTH REPORTED UPS DISCHARGED AND AFTER THE UPS WAS SWAPPED, THE SCREEN STOPPED WORKING DUE TO BAD TRANSFORMER. WHEN THEY REPLACED THE SCREEN, THE KEYBOARD, MOUSE, AND ON-SCREEN KEYBOARD STOPPED WORKING. THIS NEW SCREEN HAS NO TOUCH INPUT ON PU-621RA WITH SERIAL# (B)(6). INVESTIGATION SUMMARY: ROOT CAUSE OF THE ISSUE WAS UPS DISCHARGING FOLLOWED BY BAD TRANSFORMER ON SCREEN. THE WARRANTY OF CNS DEVICE WAS VALID TILL 09/11/2013. ACCORDING TO THE TABLE IN QUALITY COMPLAINT INVESTIGATIONS WORK INSTRUCTION, WITH DOCUMENT ID: SOP06-075, THE RISK PRIORITY OF THE ISSUE IS CATEGORIZED AS: MEDIUM. ADDITIONAL MODEL INFORMATION: D11 & C2: THE FOLLOWING 4 BSM'S WERE USED IN CONJUNCTION WITH THE CNS, BUT DID NOT EXPERIENCE A FAILURE: BSM - MODEL: MU-651RA, S/N: (B)(6), APPROXIMATE AGE OF THE DEVICE: 104 MONTHS, DEVICE MANUFACTURER DATE: 05/25/2011, UNIQUE IDENTIFIER (UDI) #: (B)(4). BSM - MODEL: MU-651RA, S/N: (B)(6), APPROXIMATE AGE OF THE DEVICE: 104 MONTHS, DEVICE MANUFACTURER DATE: 05/25/2011, UNIQUE IDENTIFIER (UDI) #: (B)(4). BSM - MODEL: MU-651RA, S/N: (B)(6), APPROXIMATE AGE OF THE DEVICE: 104 MONTHS, DEVICE MANUFACTURER DATE: 05/25/2011, UNIQUE IDENTIFIER (UDI) #: (B)(4). BSM - MODEL: MU-651RA, S/N: (B)(6), APPROXIMATE AGE OF THE DEVICE: 104 MONTHS, DEVICE MANUFACTURER DATE: 05/25/2011, UNIQUE IDENTIFIER (UDI) #: (B)(4). 10 TRANSMITTERS WERE USED IN CONJUNCTION WITH THE CNS BUT DID NOT EXPERIENCE A FAILURE. ATTEMPTS TO OBTAIN THE FOLLOWING INFORMATION WERE MADE, BUT NOT PROVIDED: MULTIPLE TRANSMITTER - MODEL: ZM-520PA, S/N: NI, APPROXIMATE AGE OF THE DEVICE: NO SERIAL NUMBER WAS PROVIDED, SO THE AGE OF THE DEVICE IS UNKNOWN. DEVICE MANUFACTURER DATE: NI. UNIQUE IDENTIFIER (UDI) #: NI. MULTIPLE TRANSMITTER - MODEL: ZM-530PA, S/N: NI, APPROXIMATE AGE OF THE DEVICE: NO SERIAL NUMBER WAS PROVIDED, SO THE AGE OF THE DEVICE IS UNKNOWN. DEVICE MANUFACTURER DATE: NI. UNIQUE IDENTIFIER (UDI) #: NI. A UPS WAS USED IN CONJUNCTION WITH THE CNS AND IS ALSO THE DEVICE THAT EXPERIENCE FAILURE. ATTEMPTS TO OBTAIN THE FOLLOWING INFORMATION WERE MADE, BUT NOT PROVIDED: UPS - MODEL: NI, S/N: NI, APPROXIMATE AGE OF THE DEVICE: NO SERIAL NUMBER WAS PROVIDED, SO THE AGE OF THE DEVICE IS UNKNOWN. DEVICE MANUFACTURER DATE: NI, UNIQUE IDENTIFIER (UDI) #: NI.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THEIR FAILED UNINTERRUPTIBLE POWER SUPPLY (UPS) CAUSED THE CENTRAL NURSE'S STATION (CNS) SCREEN TO STOP WORKING.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THEIR FAILED UNINTERRUPTIBLE POWER SUPPLY (UPS) CAUSED THE CENTRAL NURSE'S STATION (CNS) SCREEN TO STOP WORKING. THE CUSTOMER ALSO REPORTED THAT WHEN THEY REPLACED THE SCREEN, THEY WERE UNABLE TO USE THEIR PHYSICAL KEYBOARD NOR THE ON-SCREEN KEYBOARD TO INPUT PATIENT INFORMATION. THE CUSTOMER DECIDED TO REBOOT THE CNS, AFTER WHICH EVERYTHING STARTED WORKING AS INTENDED. NO HARM OR INJURY 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. CONCOMITANT MEDICAL PRODUCTS: THE FOLLOWING 4 BSM'S WERE USED IN CONJUNCTION WITH THE CNS, BUT DID NOT EXPERIENCE A FAILURE: BSM - MODEL: MU-651RA, S/N: (B)(4), APPROXIMATE AGE OF THE DEVICE: 104 MONTHS, DEVICE MANUFACTURER DATE: 05/25/2011, UNIQUE IDENTIFIER (UDI) #: (B)(4). BSM - MODEL: MU-651RA, S/N: (B)(4), APPROXIMATE AGE OF THE DEVICE: 104 MONTHS, DEVICE MANUFACTURER DATE: 05/25/2011, UNIQUE IDENTIFIER (UDI) #: (B)(4). BSM - MODEL: MU-651RA, S/N: (B)(4), APPROXIMATE AGE OF THE DEVICE: 104 MONTHS, DEVICE MANUFACTURER DATE: 05/25/2011, UNIQUE IDENTIFIER (UDI) #: (B)(4). BSM - MODEL: MU-651RA, S/N: (B)(4), APPROXIMATE AGE OF THE DEVICE: 104 MONTHS, DEVICE MANUFACTURER DATE: 05/25/2011, UNIQUE IDENTIFIER (UDI) #: (B)(4). 10 TRANSMITTERS WERE USED IN CONJUNCTION WITH THE CNS BUT DID NOT EXPERIENCE A FAILURE. ATTEMPTS TO OBTAIN THE FOLLOWING INFORMATION WERE MADE, BUT NOT PROVIDED: MULTIPLE TRANSMITTER - MODEL: ZM-520PA, S/N: NI, APPROXIMATE AGE OF THE DEVICE: NO SERIAL NUMBER WAS PROVIDED, SO THE AGE OF THE DEVICE IS UNKNOWN. DEVICE MANUFACTURER DATE: NI, UNIQUE IDENTIFIER (UDI) #: NI. MULTIPLE TRANSMITTER - MODEL: ZM-530PA, S/N: NI, APPROXIMATE AGE OF THE DEVICE: NO SERIAL NUMBER WAS PROVIDED, SO THE AGE OF THE DEVICE IS UNKNOWN. DEVICE MANUFACTURER DATE: NI, UNIQUE IDENTIFIER (UDI) #: NI. A UPS WAS USED IN CONJUNCTION WITH THE CNS AND IS ALSO THE DEVICE THAT EXPERIENCE FAILURE. ATTEMPTS TO OBTAIN THE FOLLOWING INFORMATION WERE MADE, BUT NOT PROVIDED: UPS - MODEL: NI, S/N: NI, APPROXIMATE AGE OF THE DEVICE: NO SERIAL NUMBER WAS PROVIDED, SO THE AGE OF THE DEVICE IS UNKNOWN. DEVICE MANUFACTURER DATE: NI, UNIQUE IDENTIFIER (UDI) #: NI.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR FAILED UNINTERRUPTIBLE POWER SUPPLY (UPS) CAUSED THE CENTRAL NURSE'S STATION (CNS) SCREEN TO STOP WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149690 CNS-6201A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6201A NA 04931921114131

    Patients

    Seq Age Sex Outcome Treatment
    1 10 TRANSMITTERS| 10 TRANSMITTERS| 4 BEDSIDE MONITOR'S (BSM'S)| 4 BEDSIDE MONITOR'S (BSM'S)| UPS| UPS| 10 TRANSMITTERS| 4 BEDSIDE MONITOR'S (BSM'S)| UPS