BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 12215132 · Received July 22, 2021

    Report

    Report Number
    2080783-2021-00427
    Event Type
    Malfunction
    Date Received
    July 22, 2021
    Date of Event
    June 22, 2021
    Report Date
    July 22, 2021
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    OK, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIOMEDICAL ENGINEER REPORTED THAT MULTIPLE GZ TELEMETRY TRANSMITTERS ARE IN COMMUNICATION LOSS ON THE CENTRAL NURSE'S STATION (CNS). THIS IS HAPPENING ON ALL GZS ON THE .29 SEGMENT. THIS HAPPENED AT 7:45 AM AND 8:15 AM. THIS LASTED FOR ABOUT 15 TO 20 SECONDS. THE BIOMED BELIEVES THAT THE IP ADDRESSES USED BY THE GZS COULD BE THE PROBLEM. HE SAID THAT THE GZ IP RANGE IS (B)(6). NIHON KOHDEN TECHNICAL SUPPORT (TECH SUPPORT) TOLD THEM THAT THEY SHOULD NOT USE THE IP: (B)(6) AS ONE OF THE IP ADDRESSES FOR THE GZ. HE ACKNOWLEDGED THIS. HE ASKED THAT WE LOOK INTO WHY THE COMM LOSS HAPPENED AND IF WE CAN FIND OUT WHAT IPS ARE AVAILABLE ON THE .29 SEGMENT. HE WANTS TO RE-IP THESE GZS AND WANTS TO MOVE THEM HIGHER IP IN THE IP ADDRESS RANGE. HE IS THINKING ABOUT PUTTING THEM AT (B)(6) OR HIGHER. HE ASKED IF WE COULD PROVIDE UP WITH A LIST OF 44 IPS TO USE ON THEIR GZS FOR THE .29 SEGMENT. NIHON KOHDEN COMPUTER INFORMATION TECHNOLOGY SYSTEMS SUPPORT (CITS) WAS NOT SEEING A 29 SEGMENT ON THE T DRIVE, REACHING OUT TO NETWORK TEAM. TECH SUPPORT SPOKE TO THE BIOMED TO FIND OUT ABOUT THEIR .29 SEGMENT. HE SAID THAT THEY HAVE A .29 SEGMENT, AND THEY HAD AN INSTALLER COME ON-SITE TO ASSIST THEM AROUND MARCH 4TH. NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER REPORTED THAT MULTIPLE GZ TELEMETRY TRANSMITTERS ARE IN COMMUNICATION LOSS ON THE CENTRAL NURSE'S STATION (CNS). THIS IS HAPPENING ON ALL GZS ON THE .29 SEGMENT. THIS HAPPENED AT 7:45 AM AND 8:15 AM. THIS LASTED FOR ABOUT 15 TO 20 SECONDS. THE BIOMED BELIEVES THAT THE IP ADDRESSES USED BY THE GZS COULD BE THE PROBLEM. HE SAID THAT THE GZ IP RANGE IS (B)(6). NIHON KOHDEN TECHNICAL SUPPORT (TECH SUPPORT) TOLD THEM THAT THEY SHOULD NOT USE THE IP: (B)(6) AS ONE OF THE IP ADDRESSES FOR THE GZ. HE ACKNOWLEDGED THIS. HE ASKED THAT WE LOOK INTO WHY THE COMM LOSS HAPPENED AND IF WE CAN FIND OUT WHAT IPS ARE AVAILABLE ON THE .29 SEGMENT. HE WANTS TO RE-IP THESE GZS AND WANTS TO MOVE THEM HIGHER IP IN THE IP ADDRESS RANGE. HE IS THINKING ABOUT PUTTING THEM AT (B)(6) OR HIGHER. HE ASKED IF WE COULD PROVIDE UP WITH A LIST OF 44 IPS TO USE ON THEIR GZS FOR THE .29 SEGMENT. NIHON KOHDEN COMPUTER INFORMATION TECHNOLOGY SYSTEMS SUPPORT (CITS) WAS NOT SEEING A 29 SEGMENT ON THE T DRIVE, REACHING OUT TO NETWORK TEAM. TECH SUPPORT SPOKE TO THE BIOMED TO FIND OUT ABOUT THEIR .29 SEGMENT. HE SAID THAT THEY HAVE A .29 SEGMENT, AND THEY HAD AN INSTALLER COME ON-SITE TO ASSIST THEM AROUND MARCH 4TH. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1107161 NI CENTRAL MONITOR STATION MHX NIHON KOHDEN CORPORATION NI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 GZ-130PA SN (B)(4)