BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6801A

    MDR report key: 8858079 · Received August 2, 2019

    Report

    Report Number
    8030229-2019-00335
    Event Type
    Malfunction
    Date Received
    August 2, 2019
    Date of Event
    July 10, 2019
    Report Date
    August 24, 2021
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921131640
    PMA / PMN Number
    K102376
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE CUSTOMER REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) WENT INTO COMM LOSS WITH TWO AMBULATORY VITAL SIGNS DEVICES (TRANSMITTERS: GZ-120PA). NO PATIENT HARM WAS REPORTED. SERVICE REQUESTED/PERFORMED: TROUBLESHOOTING. INVESTIGATION SUMMARY: THE OVERALL RISK SCORE IS DETERMINED TO BE HIGH. AS THE REPORTED COMPLAINT RELATES TO COMM LOSS WITH THE CNS AND GZ TRANSMITTERS, WIRELESS NETWORK DATA NEEDED TO BE COLLECTED AND COMPARED WITH PROVIDED DEVICE LOGS IN ORDER TO FIND A CAUSE OF THE COMM LOSS. THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED. AS THIS ISSUE HAS AN OVERALL RISK SCORE OF HIGH, A CAPA IS REQUIRED PER CORRECTIVE ACTION AND PREVENTIVE ACTION PROCESS, SOP07-003. SINCE THE ROOT CAUSE WAS UNABLE TO BE DETERMINED, NO CAPA IS INITIATED. WITHOUT A ROOT CAUSE, THE COUNTER MEASURE TO PREVENT RECURRENCE CANNOT BE PERFORMED. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICES WERE USED IN CONJUNCTION WITH THE CNS: GZ TRANSMITTERS: MODEL #: GZ-120PA; SN: (B)(6); MODEL #: GZ-120PA; SN: (B)(6).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE CENTRAL MONITORING SYSTEM (CNS) WENT INTO COMM LOSS WITH TWO AMBULATORY VITAL SIGNS DEVICES (GZ120PA). NO CONSEQUENCE OR IMPACT TO THE PATIENTS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    THE MONITOR TECH INDICATED THAT IT IS A HOSPITAL WI-FI ISSUE. THE FURTHER AWAY FROM THE DOOR THE PATIENT SITS, THE WORSE THE SIGNAL IS AND COMMUNICATION IS LOST. CONTINUED TROUBLESHOOTING IS NEEDED AND IS CURRENTLY BEING PERFORMED. NIHON KOHDEN CONTINUES TO INVESTIGATE THE REPORTED EVENT. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE. THE FOLLOWING DEVICES WERE BEING USED IN CONJUNCTION WITH THE CNS: GZ120PA (SN# (B)(4)). GZ120PA (SN# (B)(4)).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE CENTRAL MONITORING SYSTEM (CNS) WENT INTO COMM LOSS WITH TWO AMBULATORY VITAL SIGNS DEVICES (GZ120PA). NO CONSEQUENCE OR IMPACT TO THE PATIENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648487 CNS-6801A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6801A NA 04931921131640

    Patients

    Seq Age Sex Outcome Treatment
    1 GZ TRANSMITTER| GZ120PA