BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WATCHPAT 300

    MDR report key: 17407005 · Received July 25, 2023

    Report

    Report Number
    MW5120179
    Event Type
    Malfunction
    Date Received
    July 25, 2023
    Date of Event
    June 28, 2023
    Report Date
    July 21, 2023
    Manufacturer
    ITAMAR MEDICAL
    Product Code
    MNR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    (B)(6) 2023 11:29 AM BY RISK, RDE--- PATIENT WAS PLACED ON WATCHPAT SLEEP TESTING DEVICE (B)(6) 2023. PATIENT RETURNED THE DEVICE THE NEXT DAY. THE PATIENT CAME BACK WITH A BURN ON HIS LEFT INDEX FINGER FROM THE PULSE OXIMETER. IT DISTURBED HIS SLEEP AND HE HAD TO TAKE IT OFF DUE TO INTENSE DISCOMFORT. MANAGER SPOKE TO PATIENT AND OFFERED SITE TO BE ASSESSED IN AUC OR WITH PRIMARY CARE PHYSICIAN. MEMBER DECLINED AND SAID THAT HE WAS NOT IN PAIN NOR WAS THE SITE SWOLLEN. DEVICE WAS REMOVED FROM ROTATION AND WILL NEED TO BE TESTED AND INSPECTED BY THE VENDOR FOR SAFETY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1466503 WATCHPAT 300 VENTILATORY EFFORT RECORDER MNR ITAMAR MEDICAL 139515

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other