BEUDAMED
    FDA Adverse Event Summary report: N

    WATCH PAT 200

    MDR report key: 7568825 · Received June 4, 2018

    Report

    Report Number
    MW5077631
    Date Received
    June 4, 2018
    Date of Event
    May 21, 2018
    Report Date
    June 1, 2018
    Manufacturer
    ITAMAR MEDICAL INC.
    Product Code
    MNR
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I USED THE WATCH PAT 200 FOR MY SLEEP APNEA AND I DON'T THINK THE DEVICE IS FUNCTIONING RIGHT. I DON'T THINK THEY ARE CALIBRATING THE DEVICE RIGHT IN THEIR OFFICE FOR REPAIR. DATE OF USE: 8 HOURS. DIAGNOSIS OR REASON FOR USE: SLEEP ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408371 WATCH PAT 200 VENTILATORY EFFORT RECORDER MNR ITAMAR MEDICAL INC. WATCH PAT 200

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR