BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVIVO CORPORATION

    MDR report key: 6116431 · Received November 21, 2016

    Report

    Report Number
    1051786-2016-00016
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Report Date
    October 31, 2016
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MWI
    PMA / PMN Number
    K053462
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    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 INITIALLY REPORTED THAT THE ¿SPEAKER DOES NOT WORK OPTIMALLY¿. THIS WAS LATER DESCRIBED AS THE SOUND OF THE ALARM BEING DISTURBED AND THAT SOMETIMES THERE WAS NO SOUND AT ALL AND SOMETIMES IT WAS WORKING FINE. THERE WAS NO REPORTED PATIENT AND/OR USER IMPACT AS A RESULT OF THE REPORTED PROBLEM. THE DEVICE WAS NOT IN USE WHEN THE ISSUE WAS DISCOVERED.

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY REPORTED THAT THE ¿SPEAKER DOES NOT WORK OPTIMALLY¿. THIS WAS LATER DESCRIBED AS THE SOUND OF THE ALARM BEING DISTURBED AND THAT SOMETIMES THERE WAS NO SOUND AT ALL AND SOMETIMES IT WAS WORKING FINE. THE ISSUE WAS DISCOVERED BY PHILIPS PERSONNEL DURING PREVENTIVE MAINTENANCE OF THE DEVICE. THERE WAS NO REPORTED PATIENT AND/OR USER IMPACT AS A RESULT OF THE REPORTED PROBLEM. THE DEVICE WAS NOT IN USE WHEN THE ISSUE WAS DISCOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769785 INVIVO CORPORATION PATIENT MONITOR MWI INVIVO CORPORATION 865485

    Patients

    Seq Age Sex Outcome Treatment
    1