BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6201

    MDR report key: 5059769 · Received September 7, 2015

    Report

    Report Number
    8030229-2015-00246
    Event Type
    Malfunction
    Date Received
    September 7, 2015
    Date of Event
    August 8, 2015
    Report Date
    August 8, 2015
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    PMA / PMN Number
    K102376
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NIHON KOHDEN CONTINUES TO INVESTIGATE THIS REPORT. IF ADDITIONAL INFORMATION IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    MANUFACTURER NARRATIVE: CLINICIAN STATES THAT THEY HAD CHANGED DEVICE FROM A TRANSMITTER TO AN NTX DEVICE. WHEN SHE WENT TO CHANGE DEVICE AND SELECT THE PREVIOUS TRANSMITTER SHE COULDN'T FIND IT IN THE GROUP. THE DEVICE WAS NEVER SENT IN FOR EVALUATION. DUE TO THE AGE OF THIS COMPLAINT, ADDITIONAL INFORMATION NECESSARY TO CONDUCT AN INVESTIGATION IS NOT READILY AVAILABLE. BASED ON THE INFORMATION PROVIDED AT THE TIME OF THE EVENT ASSESSMENT, THERE IS NO INDICATION OF PATIENT INJURY OR REPORTABLE EVENT AS A RESULT OF THIS ISSUE. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR PART 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    CLINICIAN STATES THAT THEY HAD CHANGED DEVICE FROM A TRANSMITTER TO AN NTX DEVICE. WHEN SHE WENT TO CHANGE DEVICE AND SELECT THE PREVIOUS TRANSMITTER SHE COULDN'T FIND IT IN THE GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590829 CNS-6201 CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6201

    Patients

    Seq Age Sex Outcome Treatment
    1