BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS

    MDR report key: 8732745 · Received June 25, 2019

    Report

    Report Number
    8030229-2019-00238
    Event Type
    Malfunction
    Date Received
    June 25, 2019
    Date of Event
    June 4, 2019
    Report Date
    April 23, 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
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE CUSTOMER REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) (MODEL PU-681RA) HAD 3 TRANSMITTERS DROP INTO COMM LOSS. THE TELEMETRY WAS MONITORING 3 PATIENTS AND WHEN THE HOSPITAL STAFF RETURNED FROM THEIR BREAK, THE 3 PATIENTS WERE NOT READING ON THE TELES. ALL THREE OF THE TELES SHOWED THAT NO DATA WAS BEING RECEIVED. NO PATIENT INJURY WAS REPORTED. SERVICE REQUESTED / PERFORMED: TROUBLESHOOTING. INVESTIGATION SUMMARY: THE ROOT CAUSE OF THE ISSUE CANNOT BE DETERMINED AS THERE WAS NOT ENOUGH INFORMATION FROM THE CUSTOMER. ATTEMPTS TO RETRIEVE FURTHER INFORMATION WERE MADE, BUT THE CUSTOMER WAS UNABLE TO PROVIDE THE INFORMATION. A POSSIBLE REASON FOR THE COMMUNICATION LOSS IS THAT IT OCCURS AT THE WIRELESS TERMINAL AND A DETERIORATION OF COMMUNICATION QUALITY BETWEEN THE WIRELESS TERMINAL AND ACCESS POINT CAN CAUSE THIS ISSUE TO OCCUR. THE OVERALL RISK RATING IS MEDIUM. THE FOLLOWING FIELDS CONTAIN NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED: D10: THE FOLLOWING DEVICES WERE BEING USED IN CONJUNCTION WITH THE CNS: 3 GZ TRANSMITTERS (MODEL/SN#: NI). ADDITIONAL INFORMATION: B4 DATE OF THIS REPORT. G3 DATE RECEIVED BY MANUFACTURER. G6 TYPE OF REPORT. H2 IF FOLLOW-UP, WHAT TYPE?. H6 EVENT PROBLEM AND EVALUATION CODES. H10 ADDITIONAL MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CNS SIGNAL DROPPED OUT WITH 3 GZ TRANSMITTERS DURING THE NIGHT SHIFT. NO CONSEQUENCE OR IMPACT TO THE PATIENTS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE CNS SIGNAL DROPPED OUT WITH 3 GZ TRANSMITTERS DURING THE NIGHT SHIFT. NO CONSEQUENCE OR IMPACT TO THE PATIENTS WERE REPORTED. NIHON KOHDEN CONTINUES TO INVESTIGATE THE REPORTED EVENT AND WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE. THE FOLLOWING FIELDS ARE NOT APPLICABLE (NA) TO THE MDR REPORT: LOT NUMBER & EXPIRATION . THE FOLLOWING FIELDS CONTAIN NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED: CONCOMITANT MEDICAL PRODUCTS: THE FOLLOWING DEVICES WERE BEING USED IN CONJUNCTION WITH THE CNS: 3 GZ TRANSMITTERS (MODEL/SN# UNKNOWN).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CNS SIGNAL DROPPED OUT WITH 3 GZ TRANSMITTERS DURING THE NIGHT SHIFT. NO CONSEQUENCE OR IMPACT TO THE PATIENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525880 CNS CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6801 NOT APPLICABLE 04931921131640

    Patients

    Seq Age Sex Outcome Treatment
    1 GZ TRANSMITTERS| GZ TRANSMITTERS