BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVIVO CORPORATION

    MDR report key: 1422462 · Received July 27, 2009

    Report

    Report Number
    1051786-2009-00007
    Event Type
    Other
    Date Received
    July 27, 2009
    Report Date
    December 10, 2008
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MHX
    PMA / PMN Number
    K014294
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY'S BIOMEDICAL ENGINEER CHANGED THE DEVICE'S POWER SUPPLY DUE TO THE DEVICE FAILING TO POWER UP PROPERLY. AFTER CHANGING THE POWER SUPPLY, THE BIOMEDICAL ENGINEER TESTED THE DEVICE AND NOTED THE NO SOUND CONDITION. THE AVAILABLE INFORMATION DOES NOT SUPPORT THAT THERE WAS A NO SOUND CONDITION PRESENT PRIOR TO THE REPLACEMENT OF THE POWER SUPPLY AND THAT REPLACEMENT OF THE POWER SUPPLY BY THE BIOMED CAUSED THE NO SOUND CONDITION TO OCCUR. THE DEVICE MANUFACTURER PROVIDED THE USER WITH TROUBLESHOOTING IN ORDER TO DETERMINE THE SOURCE OF THE NO SOUND CONDITION (PINCHED WIRES, LOOSE CONNECTIONS, ETC...). THE USER WAS GOING TO TRY THE SUGGESTIONS AND CALL THE DEVICE MANUFACTURER BACK, IF NECESSARY. THE USER HAS NOT CALLED BACK FOR ADDITIONAL ASSISTANCE IN RESOLVING THE REPORTED PROBLEM. THIS SUPPORTS, THAT THE USER RESOLVED THE REPORTED PROBLEM ON THEIR OWN. NO ADDITIONAL INVESTIGATION OR ACTION IS WARRANTED OR PLANNED.

    Description of Event or Problem · 1

    THE USER STATED THAT THEY REPLACED THE DEVICE'S POWER SUPPLY AND NOW THEY ARE NOT GETTING ANY SOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVIVO CORPORATION M10 PT MONITOR MHX INVIVO CORPORATION 20415

    Patients

    Seq Age Sex Outcome Treatment
    1