BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 12113758 · Received July 3, 2021

    Report

    Report Number
    2080783-2021-00388
    Event Type
    Malfunction
    Date Received
    July 3, 2021
    Date of Event
    June 3, 2021
    Report Date
    July 3, 2021
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    LA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIOMEDICAL ENGINEER REPORTED THAT THERE WAS A POWER OUTAGE, AND IT TOOK DOWN THE HOSPITAL NETWORK. THE CENTRAL NURSE'S STATION (CNS) AND REMOTE NETWORK STATION (RNS) WENT DOWN. AFTER THE POWER WAS RESTORED THE CNS WAS UP AND RUNNING WITHOUT ISSUES, BUT THE RNS ARE NOW IN COMM LOSS. THE BIOMED DID NOT HAVE SERVER ACCESS TO START UP THE APPLICATION HIMSELF. HOST 1000 APPLICATION NEEDED TO BE STARTED AFTER THE POWER OUTAGE. NIHON KOHDEN TECHNICAL SUPPORT (TECH SUPPORT) SPOKE WITH BOTH LGH AND ACADIA AND BOTH CONFIRMED THE ISSUE WAS RESOLVED. NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER REPORTED THAT THERE WAS A POWER OUTAGE, AND IT TOOK DOWN THE HOSPITAL NETWORK. THE CENTRAL NURSE'S STATION (CNS) AND REMOTE NETWORK STATION (RNS) WENT DOWN. AFTER THE POWER WAS RESTORED THE CNS WAS UP AND RUNNING WITHOUT ISSUES, BUT THE RNS ARE NOW IN COMM LOSS. THE BIOMED DID NOT HAVE SERVER ACCESS TO START UP THE APPLICATION HIMSELF. HOST 1000 APPLICATION NEEDED TO BE STARTED AFTER THE POWER OUTAGE. NIHON KOHDEN TECHNICAL SUPPORT (TECH SUPPORT) SPOKE WITH BOTH LGH AND ACADIA AND BOTH CONFIRMED THE ISSUE WAS RESOLVED. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010376 NI CENTRAL MONITOR STATION MHX NIHON KOHDEN CORPORATION NI NA

    Patients

    Seq Age Sex Outcome Treatment
    1