BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 1573831 · Received December 31, 2009

    Report

    Report Number
    3020115-2009-00001
    Event Type
    Malfunction
    Date Received
    December 31, 2009
    Date of Event
    December 13, 2009
    Report Date
    December 16, 2009
    Manufacturer
    PARKS MEDICAL ELECTRONICS, INC.
    Product Code
    MHX
    PMA / PMN Number
    K944495
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE USER WAS SHOCKED WHILE PLUGGING THE DEVICE INTO AN OUTLET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA DOPPLER BLOOD FLOW DETECTOR MHX PARKS MEDICAL ELECTRONICS, INC. 811-B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization