BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVIVO CORPORATION

    MDR report key: 1380646 · Received March 10, 2009

    Report

    Report Number
    1051786-2009-00003
    Event Type
    Malfunction
    Date Received
    March 10, 2009
    Report Date
    February 9, 2009
    Manufacturer
    INVIVO CORPORATION
    Product Code
    DRT
    PMA / PMN Number
    K974581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE INITIAL REPORTER (THE USER FACILITY'S CLINICAL ENGINEER), THE USER FACILITY FIRST TRIED REPLACING THE DEVICE'S POWER SUPPLY BOARD, BUT THIS DID NOT RECTIFY THE NO SOUND CONDITION. PER DISCUSSIONS HELD WITH THE USER FACILITY'S CLINICAL ENGINEER, THE USER FACILITY DECIDED TO SCRAP THE DEVICE DUE TO THE COST OF REPLACING ADDITIONAL BOARDS OR SENDING IT IN FOR REPAIR. AS A RESULT, THERE IS NO OPPORTUNITY FOR THE MANUFACTURER TO EVALUATE THE DEVICE IN QUESTION IN ORDER TO CONFIRM THAT AN ACTUAL MALFUNCTION HAD OCCURRED OR TO DETERMINE THE CAUSE OF THE REPORTED PROBLEM. WHILE THE DEVICE DISPLAY PROVIDES VISUAL INDICATORS OF ALARMS OCCURRING, THE DEVICE LABELING DOES NOT REPRESENT THAT DISPLAY DATA IS CONTINUOUSLY MONITORED BY STAFF. IN THE PRESENCE OF LIFE-THREATENING EVENTS WHEN NO SOUND IS AUDIBLE, AND NO STAFF MEMBER IS CONTINUOUSLY MONITORING THE DISPLAY, SERIOUS INJURY AND/OR DEATH CAN OCCUR.

    Description of Event or Problem · 1

    USER FACILITY REPORTED TO THE MANUFACTURER THAT THEY WERE NOT RECEIVING ANY ALARM TONES FROM THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVIVO CORPORATION MILLENIA PATIENT MONITOR DRT INVIVO CORPORATION 3500

    Patients

    Seq Age Sex Outcome Treatment
    1