BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WATCHPAT 300

    MDR report key: 16130382 · Received January 10, 2023

    Report

    Report Number
    16130382
    Event Type
    Malfunction
    Date Received
    January 10, 2023
    Date of Event
    December 10, 2022
    Report Date
    December 15, 2022
    Manufacturer
    ITAMAR MEDICAL, INC.
    Product Code
    MNR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT RETURNED A HOME SLEEP APNEA TESTING DEVICE (WATCHPAT 300 SN). THE PATIENT STATED THE MACHINE DIDN¿T APPEAR TO BE WORKING AND THAT WHEN HE TOOK THE DEVICE OFF, THERE WERE 3 SMALL BURN MARKS ON HIS FINGER. WHEN PUTTING THE PROBE ON HIS INDEX FINGER IT WAS VERY TIGHT, THEN IT DIDN'T SEEM LIKE THE MACHINE WANTED TO TURN ON THE WAY THE DIRECTIONS READ THE NEXT DAY. HIS FINGER HAD A SENSATION ALL DAY LONG AND THE FOLLOWING MORNING HE WOKE UP WITH BLISTERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1724507 WATCHPAT 300 VENTILATORY EFFORT RECORDER MNR ITAMAR MEDICAL, INC. WATCH-PAT300

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other