BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 9560726 · Received January 7, 2020

    Report

    Report Number
    8030229-2020-00014
    Event Type
    Malfunction
    Date Received
    January 7, 2020
    Date of Event
    December 20, 2019
    Report Date
    April 2, 2020
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    PMA / PMN Number
    NI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT INFORMATION: ON (B)(6) 2019, CUSTOMER AT (B)(6) HEALTH REPORTED COMMUNICATION LOSS ERROR FOR ALL TRANSMITTERS. CNSS AND BSM ARE OPERATING WITHOUT ISSUE. DETAILS OF TELEMETRY DEVICES RELATED TO THE ISSUE HAVE NOT BEEN REPORTED AT THE TIME OF COMPLAINT, SUCH INCIDENTS ARE ADDRESSED UNDER CAPA-18-033. INVESTIGATION SUMMARY: ROOT CAUSE OF THE ISSUE WAS IDENTIFIED TO BE USER ERROR AS MEDIA CONVERTER WAS DISCONNECTED. ACCORDING TO THE TABLE IN QUALITY COMPLAINT INVESTIGATIONS WORK INSTRUCTION, WITH DOCUMENT ID: SOP07-018, THE SEVERITY OF THE ISSUE IS CATEGORIZED AS: MODERATE. ADDITIONAL MODEL INFORMATION: D11 & C2: MULTIPLE TRANSMITTERS WERE USED IN CONJUNCTION WITH THE CNS. ATTEMPTS TO OBTAIN THE FOLLOWING INFORMATION WERE MADE, BUT NOT PROVIDED: MULTIPLE TRANSMITTERS - 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 CENTRAL NURSE'S STATION (CNS) WAS SHOWING COMMUNICATION LOSS FOR ALL TRANSMITTERS.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THEIR CENTRAL NURSE'S STATION (CNS) WAS SHOWING COMMUNICATION LOSS FOR ALL TRANSMITTERS. THE CUSTOMER ALSO REPORTED THAT THE CNS IS NOT DISPLAYING COMM LOSS FOR THEIR BEDSIDE MONITOR'S (BSM'S). NO CONSEQUENCE OR IMPACT TO THE PATIENTS WAS REPORTED. NK TS WALKED THE CUSTOMER THROUGH THE PROCESS OF CHECKING THE MULTIPLE PATIENT RECEIVER'S (ORG'S) CONNECTED TO THIS CNS AND THIS IS WHEN THEY NOTICED THAT THE MEDIA CONVERTER WAS DISCONNECTED. ONCE THE CUSTOMER RECONNECTED THE MEDIA CONVERTER ALL OF THE TRANSMITTERS CAME OUT OF COMM LOSS. 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. APPROXIMATE AGE OF THE DEVICE. NO SERIAL NUMBER WAS PROVIDED, SO THE AGE OF THE DEVICE IS UNKNOWN. ADDITIONAL MODEL INFORMATION: MULTIPLE TRANSMITTERS WERE USED IN CONJUNCTION WITH THE CNS. ATTEMPTS TO OBTAIN THE FOLLOWING INFORMATION WERE MADE, BUT NOT PROVIDED: MULTIPLE TRANSMITTERS - 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 CENTRAL NURSE'S STATION (CNS) WAS SHOWING COMMUNICATION LOSS FOR ALL TRANSMITTERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19756 NI CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION NI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 MULTIPLE TRANSMITTERS| MULTIPLE TRANSMITTERS