BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHPAT100

    MDR report key: 948034 · Received November 12, 2007

    Report

    Report Number
    MW5004413
    Event Type
    Injury
    Date Received
    November 12, 2007
    Report Date
    November 12, 2007
    Manufacturer
    ITAMAR MEDICAL LTD.
    Product Code
    MNR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE MEDICAL DEVICE IN QUESTION REPORTS APNEA HYPOPNEAS INDEX THAT IS USED FOR THE DIAGNOSIS OF SLEEP APNEA. THE CO MISLEADS THE PHYSICIANS BY CLAIMING THAT THE INDEX HAS BEEN FDA APPROVED WHEN THIS IS NOT THE CASE -FDA CASE K042916-. ACCORDING TO THE INDEX THERAPY OR NO THERAPY IS DECIDED. IF THERAPY IS MISSED AND THE PT IS NOT TREATED WHILE HE SHOULD, COMPLICATIONS MAY ARISE. A CLAIM OF SUCH AN INDEX AS FDA APPROVED WHILE IT IS NOT, CAN HAVE SERIOUS CONSEQUENCES ON THE WELL BEING OF PTS EVALUATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WATCHPAT100 WATCHPAT100 MNR ITAMAR MEDICAL LTD. WATCHPAT100

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Disability