BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 9079857 · Received September 17, 2019

    Report

    Report Number
    8030229-2019-00469
    Event Type
    Malfunction
    Date Received
    September 17, 2019
    Date of Event
    August 22, 2019
    Report Date
    December 10, 2019
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    PMA / PMN Number
    NI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF THE COMPLAINT: ON (B)(6) 2019, CUSTOMER AT (B)(6) MEDICAL CENTER REPORTED THEIR TELEMETRY SYSTEM WENT DOWN FOR SOME TIME ON AUGUST 15. FURTHER CLARIFICATION SHOWED THE ISSUE WAS RELATED TO NETKONNECT. THE CUSTOMER WAS NOT ABLE TO LOG INTO THEIR NETKONNECT SERVER DUE TO LOST PASSWORD. CUSTOMER WAS LATER ABLE TO LOG IN BY USING A COMPUTER THAT HAD THE PASSWORD AUTO-FILLED. SERVICE REQUESTED/PERFORMED: TROUBLESHOOTING/ASSISTANCE. MISSING INFORMATION/REQUIRED INFORMATION: THE DEVICE INFORMATION ASSOCIATED WITH THE COMPLAINT FILE IS NOT ENTERED IN THE "PRODUCT" FIELD. THIS IS A KNOWN ISSUE AND CAPA 18-033 HAS BEEN OPENED TO ADDRESS THIS. INVESTIGATION RESULTS: NETKONNECT IS A WEB APPLICATION WHICH ALLOWS USERS TO VIEW CURRENT AND HISTORICAL PATIENT INFORMATION EITHER WITHIN THE HOSPITAL NETWORK OR REMOTELY USING A VPN. NETKONNECT IS NOT DESIGNED TO BE USED AS A PATIENT MONITORING DEVICE AND SHOULD NOT BE USED AS A REPLACEMENT OF PATIENT MONITORING VIA THE CNS. THE CUSTOMER WAS UNABLE TO ACCESS NETKONNECT TO VIEW PATIENT INFORMATION DUE TO LACK OF PASSWORD KNOWLEDGE. THE ROOT CAUSE IS DETERMINED TO BE USER ERROR. THE REPORTED ISSUE IS NOT SUSPECTED TO BE CAUSED BY NK PRODUCT DEFICIENCY. INVESTIGATION CONCLUSION: THE CUSTOMER WAS UNABLE TO ACCESS NETKONNECT TO VIEW PATIENT INFORMATION DUE TO LACK OF PASSWORD KNOWLEDGE. THE ROOT CAUSE IS DETERMINED TO BE USER ERROR. THE REPORTED ISSUE IS NOT SUSPECTED TO BE CAUSED BY NK PRODUCT DEFICIENCY.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER REPORTED THAT THEIR TELEMETRY TRANSMITTER SYSTEM WAS DOWN. NIHON KOHDEN HAS ASKED THEM FOR CLARIFICATION ON WHAT DEVICES THIS EVENT AFFECTED AND INVOLVED, BUT NO RESPONSE WAS PROVIDED. NO PATIENT HARM WAS REPORTED.

    Additional Manufacturer Narrative · 1

    THE BIOMEDICAL ENGINEER REPORTED THAT THEIR TELEMETRY TRANSMITTER SYSTEM WAS DOWN. NIHON KOHDEN HAS ASKED THEM FOR CLARIFICATION ON WHAT DEVICES THIS EVENT AFFECTED AND INVOLVED, BUT NO RESPONSE WAS PROVIDED. 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.

    Description of Event or Problem · 1

    THE BIOMEDICAL ENGINEER REPORTED THAT THEIR TELEMETRY TRANSMITTER SYSTEM WAS DOWN. NIHON KOHDEN HAS ASKED THEM FOR CLARIFICATION ON WHAT DEVICES THIS EVENT AFFECTED AND INVOLVED, BUT NO RESPONSE WAS PROVIDED. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    871673 NI CENTRAL MONITOR STATION MHX NIHON KOHDEN CORPORATION NI NA

    Patients

    Seq Age Sex Outcome Treatment
    1