BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MWI

    MDR report key: 10546244 · Received September 17, 2020

    Report

    Report Number
    1051786-2020-00045
    Event Type
    Malfunction
    Date Received
    September 17, 2020
    Report Date
    September 8, 2020
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MWI
    UDI-DI
    00884838039131
    PMA / PMN Number
    K152330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS FOUND THAT THE SPEAKER IN THE PAN WAS LOOSE INSIDE THE DEVICE. THE BENCH TECHNICIAN REPORTED THAT HE INSTALLED INTERNAL PAN SPEAKER ADHESIVE HOLDING STRIP TO THE SPEAKER TO HOLD IT IN PLACE. FOLLOWING BENCH EVALUATION, THE DEVICE WAS RETURNED TO THE ACCOUNT MANAGER.

    Description of Event or Problem · 1

    THE ACCOUNT MANAGER REPORTED THAT THE AUDIO ON HIS DEMONSTRATION MONITOR HAD GONE OUT. AUDIO IN THIS CASE IS CONSIDERED TO MEAN ALARM ANNUNCIATION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016237 MWI PHYSIOLOGICAL PATIENT MONITOR MWI INVIVO CORPORATION 866185 00884838039131

    Patients

    Seq Age Sex Outcome Treatment
    1