BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECG-9320A

    MDR report key: 4385923 · Received December 24, 2014

    Report

    Report Number
    8030229-2014-00135
    Event Type
    Malfunction
    Date Received
    December 24, 2014
    Manufacturer
    NIHON KOHDEN CORP.
    Product Code
    GWQ
    PMA / PMN Number
    K961272
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED FOR REPAIR. PER THE CUSTOMER THE DEVICE IS NO LONGER IN SERVICE. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF ANY PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850198 ECG-9320A ELECTRTOENCEPHALOGRAPH GWQ NIHON KOHDEN CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1