BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GZ-130PA

    MDR report key: 9142699 · Received October 1, 2019

    Report

    Report Number
    8030229-2019-00508
    Event Type
    Malfunction
    Date Received
    October 1, 2019
    Date of Event
    September 9, 2019
    Report Date
    February 16, 2022
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    DRT
    UDI-DI
    04931921117415
    PMA / PMN Number
    K153707
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT PATIENT INFORMATION AND DATA WAS DISAPPEARING FROM THE CENTRAL NURSE'S STATION (CNS) WHEN MONITORING THIS TRANSMITTER. VITAL SIGNS WERE NOT ALWAYS BEING STORED AND WHEN THEY DID, PATIENT INFORMATION WOULD DISAPPEAR. WHEN MOVING THIS TRANSMITTER TO OTHER CNS DEVICES, THE ISSUE WAS DUPLICATED. NO PATIENT HARM WAS REPORTED. SERVICE REQUESTED: AN EXCHANGE UNIT WAS SHIPPED TO THE CUSTOMER ON 09/25/2019. SERVICE PERFORMED: EVALUATION: ON 01/12/2022, THE RETURNED UNIT WAS CLEANED AND DECONTAMINATED BY NIHON KOHDEN AMERICA REPAIR CENTER (NKA RC). UPON RC EVALUATION, THE REPORTED PROBLEM WAS DUPLICATED. A PROBLEM WITH THE MAIN BOARD WAS FOUND AND THE BATTERY DOOR COVER WAS MISSING. THERE WAS ALSO A RATTLING SOUND COMING FROM INSIDE THE UNIT. INVESTIGATION SUMMARY: AS PER NKA RC EVALUATION, THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE FAILURE OF THE POWER BOARD DUE TO PHYSICAL DAMAGE. THE REPORTED ISSUE DOES NOT REQUIRE FURTHER INVESTIGATION THROUGH CAPA PROCESS SINCE THE ISSUE WAS FOUND TO HAVE BEEN CAUSED BY PHYSICAL DAMAGE SUSTAINED TO THE UNIT AND NOT A DEVIATION FROM ITS INTENDED PERFORMANCE. THE FOLLOWING FIELDS CONTAIN NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED: A2 - A6. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE(S) WERE USED IN CONJUNCTION WITH THE TRANSMITTER: CNS: MODEL #: CNS-6801 SERIAL #: (B)(6).

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT PATIENT INFORMATION AND DATA WAS DISAPPEARING FROM THE CENTRAL NURSE'S STATION (CNS) WHEN MONITORING THIS TRANSMITTER. VITAL SIGNS WERE NOT ALWAYS BEING STORED AND WHEN THEY DID, PATIENT INFORMATION WOULD DISAPPEAR. WHEN MOVING THIS TRANSMITTER TO OTHER CNS DEVICES, THE ISSUE WAS DUPLICATED. NO PATIENT HARM WAS REPORTED.

    Additional Manufacturer Narrative · 1

    THE BIOMEDICAL ENGINEER REPORTED THAT PATIENT INFORMATION AND DATA WOULD DISAPPEAR FROM THE CENTRAL NURSE'S STATION (CNS) WHEN MONITORING THIS TRANSMITTER. VITAL SIGNS WERE NOT ALWAYS BEING STORED AND WHEN THEY DID, PATIENT INFORMATION WOULD DISAPPEAR. THIS IS ISSUE WAS DUPLICATED ON OTHER CNS DEVICES, THUS FOLLOWING THE TRANSMITTER. 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. ADDITIONAL DEVICE INFORMATION: CONCOMITANT MEDICAL DEVICE INFORMATION: CENTRAL NURSE'S STATION , MODEL: CNS-6801, SN: (B)(4).

    Description of Event or Problem · 1

    THE BIOMEDICAL ENGINEER REPORTED THAT PATIENT INFORMATION AND DATA WOULD DISAPPEAR FROM THE CENTRAL NURSE'S STATION (CNS) WHEN MONITORING THIS TRANSMITTER. VITAL SIGNS WERE NOT ALWAYS BEING STORED AND WHEN THEY DID, PATIENT INFORMATION WOULD DISAPPEAR. THIS IS ISSUE WAS DUPLICATED ON OTHER CNS DEVICES, THUS FOLLOWING THE TRANSMITTER. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    936882 GZ-130PA TRANSMITTER DRT NIHON KOHDEN CORPORATION GZ-130PA NA 04931921117415

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CNS (CNS-6801 SN (B)(6))| CNS-6801 SN (B)(6).| CNS-6801 SN (B)(4)