BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6201A

    MDR report key: 10602234 · Received September 29, 2020

    Report

    Report Number
    8030229-2020-00579
    Event Type
    Malfunction
    Date Received
    September 29, 2020
    Date of Event
    September 2, 2020
    Report Date
    November 11, 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
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: ON (B)(6) 2020, THE CUSTOMER AT (B)(6) REPORTED THE FOLLOWING ISSUE WITH A/RNS-9703-024; SN-(B)(6), FROM PATIENT MONITORING: COMMUNICATION LOSS ON MULTIPLE TELEMETRY DEVICES ON ALL AFFECTED RNSS/CNSS (PU-621RA SN: (B)(6) ). INVESTIGATION SUMMARY: THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE DEFECTIVE MEDIA CONVERTERS FOR THE RESPECTIVE DEVICES EXPERIENCING COMMUNICATION LOSS.THE OVERALL RISK OF THIS EVENT, TAKING INTO CONSIDERATION OF SEVERITY AND PROBABILITY, IS "MEDIUM". THE REPORTED ISSUE DOES NOT REQUIRE FURTHER INVESTIGATION THROUGH CAPA PROCESS, BECAUSE THE CAUSE OF THE MALFUNCTION WAS HOSPITAL INFRASTRUCTURE RELATED AND NOT NK DEVICE PERFORMANCE DEVIATION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THEIR CENTRAL NURSE STATION (CNS) IS EXPERIENCING COMMUNICATION LOSS WITH MULTIPLE TELEMETRY DEVICES.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THEIR CENTRAL NURSE STATION (CNS) IS EXPERIENCING COMMUNICATION LOSS WITH MULTIPLE TELEMETRY DEVICES. NK TS ASSISTED THE CUSTOMER IN TROUBLESHOOTING AND HAD THEM REPLACE THE MEDIA CONVERTERS FOR THE RNS AND ORG WHICH RESTORED NETWORK COMMUNICATION. NIHON KOHDEN CONTINUES TO INVESTIGATE THE REPORTED EVENT. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE. ADDITIONAL MODEL INFORMATION: MULTIPLE TRANSMITTERS WERE USED IN CONJUNCTION WITH THE CNS, AND ARE NOT THE DEVICES THAT EXPERIENCED FAILURE. ATTEMPTS TO OBTAIN THE FOLLOWING INFORMATION WERE MADE, BUT NOT PROVIDED: TRANSMITTERS - MODEL: NI, S/N: NI. APPROXIMATE AGE OF THE DEVICE: NI. NO SERIAL NUMBER WAS PROVIDED, SO THE AGE OF THE DEVICE IS UNKNOWN. DEVICE MANUFACTURER DATE: NI UNIQUE IDENTIFIER (UDI) #: NI. MULTIPLE ORGS WERE USED IN CONJUNCTION WITH THE CNS, AND ARE NOT THE DEVICES THAT EXPERIENCED FAILURE. ATTEMPTS TO OBTAIN THE FOLLOWING INFORMATION WERE MADE, BUT NOT PROVIDED: ORGS - MODEL: NI, S/N: NI. APPROXIMATE AGE OF THE DEVICE: NI. NO SERIAL NUMBER WAS PROVIDED, SO THE AGE OF THE DEVICE IS UNKNOWN. DEVICE MANUFACTURER DATE: NI UNIQUE IDENTIFIER (UDI) #: NI. MULTIPLE RNSS WERE USED IN CONJUNCTION WITH THE CNS, AND ARE NOT THE DEVICES THAT EXPERIENCED FAILURE. ATTEMPTS TO OBTAIN THE FOLLOWING INFORMATION WERE MADE, BUT NOT PROVIDED: RNSS - MODEL: NI S/N: NI APPROXIMATE AGE OF THE DEVICE: NI. 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 CENTRAL NURSE STATION (CNS) IS EXPERIENCING COMMUNICATION LOSS WITH MULTIPLE TELEMETRY DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1065215 CNS-6201A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6201A NA 04931921114131

    Patients

    Seq Age Sex Outcome Treatment
    1 MULTIPLE ORGS| MULTIPLE ORGS| MULTIPLE RNSS| MULTIPLE RNSS| MULTIPLE TRANSMITTERS| MULTIPLE TRANSMITTERS