BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVIVO CORPORATION

    MDR report key: 6137921 · Received December 1, 2016

    Report

    Report Number
    1051786-2016-00018
    Event Type
    Malfunction
    Date Received
    December 1, 2016
    Report Date
    November 7, 2016
    Manufacturer
    INVIVO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K103700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE IS NO SOUND COMING FROM THE DEVICE. THERE WAS NO REPORTED PATIENT IMPACT. THE DEVICE WAS REPORTEDLY NOT IN USE WHEN THE PROBLEM WAS DISCOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790635 INVIVO CORPORATION PATIENT MONITOR DQA INVIVO CORPORATION 865353

    Patients

    Seq Age Sex Outcome Treatment
    1