BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONYAIR

    MDR report key: 17884983 · Received October 6, 2023

    Report

    Report Number
    1043572-2023-00144
    Event Type
    Malfunction
    Date Received
    October 6, 2023
    Date of Event
    September 7, 2023
    Report Date
    October 6, 2023
    Manufacturer
    STERIS CORPORATION
    Product Code
    FQO
    UDI-DI
    00724995153472
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A STERIS SERVICE TECHNICIAN ARRIVED ON SITE TO INSPECT THE MONITOR CARRIER AND WAS ABLE TO DETERMINE THAT THE PLASTIC COVER WAS NOT FULLY ATTACHED TO THE UNDERSIDE OF THE MONITOR SPRING ARM. THE TECHNICIAN SNAPPED THE COVER PIECES TOGETHER AND VERIFIED THEY WERE SECURE. ADDITIONALLY, THE TECHNICIAN EXAMINED ALL COVER PIECES WITHIN THE ROOM TO ENSURE THEY WERE ALSO SECURE. AFTER MAKING APPROPRIATE ADJUSTMENTS AND TESTING ALL EQUIPMENT WITHIN THE ROOM, THE TECHNICIAN CONFIRMED THE UNITS TO BE OPERATING ACCORDING TO SPECIFICATION. THE TECHNICIAN WAS RE-TRAINED ON PROPER INSTALLATION ACTIVITIES FOR THE HARMONYAIR MONITOR CARRIER WITH SPECIFIC FOCUS ON PROPER COVER INSTALLATION. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY: ALIGNMENT WITH GUDID. THE SERIAL NUMBER LISTED IN MDR 1043572-2023-00144 WAS INCORRECT BY ONE DIGIT. THE SERIAL NUMBER WAS CORRECTED IN MDR 1043572-2023-00144-01.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE PLASTIC COVER TO THEIR HARMONYAIR MONITOR CARRIER FELL OFF DURING USE. NO REPORT OF PROCEDURE DELAYS/CANCELLATIONS. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219652 HARMONYAIR HARMONYAIR MONITOR CARRIER FQO STERIS CORPORATION MONITOR CARRIER 00724995153472

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown