BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 12215018 · Received July 22, 2021

    Report

    Report Number
    8030229-2021-00427
    Event Type
    Malfunction
    Date Received
    July 22, 2021
    Date of Event
    June 22, 2021
    Report Date
    February 23, 2023
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    PMA / PMN Number
    NI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE GZ TELEMETRY TRANSMITTERS WERE IN COMM LOSS AT THE CENTRAL NURSE'S STATION (CNS). THIS WAS HAPPENING ON THE .29 SEGMENT AND LASTED FOR ABOUT 15 TO 20 SECONDS. NO PATIENT HARM OR INJURY WAS REPORTED. INVESTIGATION SUMMARY: THE CUSTOMER VERIFIED THE IP ADDRESSES FOR THE GZ TRANSMITTERS AND FOUND THEM BOTH TO BE ON THE .29 SEGMENT. NIHON KOHDEN TECHNICAL SUPPORT (NK TS) INFORMED THE CUSTOMER THAT ONE OF THE IP ADDRESSES SHOULD NOT BE USED WITH GZ TRANSMITTERS. THEY ASKED FOR A LIST OF AVAILABLE IP ADDRESSES ON THE .29 SEGMENT. NK TS REACHED OUT TO CLINICAL (CITS) FOR ASSISTANCE AND THE AVAILABLE IP ADDRESSES WERE PROVIDED. WITH THE AVAILABLE INFORMATION, THE ROOT CAUSE IS DETERMINED TO BE THE FACILITY'S NETWORK ENVIRONMENT AND USE ERROR. IP ADDRESS DUPLICATION OR THE USING THE INCORRECT SEGMENT FOR THE GZ TRANSMITTERS WILL CAUSE COMM LOSS ISSUES. REVIEW OF THE SERIAL NUMBER HISTORY SHOWS NO RECURRENCE OF THE REPORTED ISSUE.

    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 172.16.29.1 TO 172.16.29.44. NIHON KOHDEN TECHNICAL SUPPORT (TECH SUPPORT) TOLD THEM THAT THEY SHOULD NOT USE THE IP: 172.16.29.1 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 172.16.29.100 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. 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. CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE(S) WERE BEING USED IN CONJUNCTION WITH THE CNS. TELEMETRY TRANSMITTER MODEL: GZ-130PA, SN: (B)(4).

    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 LASTED FOR ABOUT 15 TO 20 SECONDS. THE BIOMED BELIEVES THAT THE IP ADDRESSES USED BY THE GZS COULD BE THE PROBLEM.

    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 172.16.29.1 TO 172.16.29.44. NIHON KOHDEN TECHNICAL SUPPORT (TECH SUPPORT) TOLD THEM THAT THEY SHOULD NOT USE THE IP: 172.16.29.1 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 172.16.29.100 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
    1108857 NI CENTRAL MONITOR STATION MHX NIHON KOHDEN CORPORATION NI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown (B)(6). SN (B)(6).| TRANSMITTER (B)(6).