BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVIVO CORPORATION

    MDR report key: 5038341 · Received August 28, 2015

    Report

    Report Number
    1051786-2015-00009
    Event Type
    Malfunction
    Date Received
    August 28, 2015
    Report Date
    August 14, 2015
    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 WHEN THEY TURNED THE DEVICE ON, THE ALARM DIDN'T MAKE A SOUND. THERE WAS NO REPORTED PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573471 INVIVO CORPORATION PATIENT MONITOR DQA INVIVO CORPORATION 865353

    Patients

    Seq Age Sex Outcome Treatment
    1