BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FREQUENCY VENTED HUMIDIFICATION CHAMBER

    MDR report key: 4299094 · Received December 4, 2014

    Report

    Report Number
    9611451-2014-00883
    Event Type
    Malfunction
    Date Received
    December 4, 2014
    Date of Event
    October 28, 2014
    Report Date
    November 5, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THREE COMPLAINT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) AND WERE VISUALLY INSPECTED. THE LOT INFORMATION IS AS FOLLOWS: ONE CHAMBER (DEVICE 1) FROM LOT 130911, MANUFACTURED 11 SEP 2013. TWO CHAMBERS (DEVICE 2 AND DEVICE 3) FROM LOT 140304, MANUFACTURED 04 MAR 2014. RESULTS: VISUAL INSPECTION REVEALED THAT FOR ALL THREE COMPLAINT DEVICES, THE CHAMBER DOME WAS CRACKED. ADDITIONALLY SMEARED PRINTS, WHITE RESIDUE AND FLOW MARKS WERE PRESENT ON THE CHAMBER DOMES: FOR DEVICE 1 AND DEVICE 2, FLOW MARKS WERE NOTED ON THE CHAMBERS. VISUAL INSPECTION ALSO REVEALED WHITE RESIDUE ON DEVICE 2. FOR DEVICE 1 AND DEVICE 3, THE PRINTING ON THE DOME WAS OBSERVED TO BE SLIGHTLY SMEARED. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 130911 AND LOT 140304. CONCLUSION: THE SMEARED PRINTS, FLOW MARKS AND WHITE RESIDUE ON THE DEVICES INDICATE THAT THE CHAMBERS WERE IN CONTACT WITH A SOLUTION CONTAINING ALCOHOL WHICH RESULTED IN ENVIRONMENTAL STRESS CRACKING OF THE CHAMBER DOMES. EVERY MR290 CHAMBER IS PRESSURE TESTED FOLLOWING THE MANUFACTURING PROCESS TO CHECK FOR ANY LEAKS PRESENT IN THE CHAMBER DOME DUE TO CRACKS AND OTHER CAUSES. ANY CHAMBER WHICH FAILS THIS TEST IS REJECTED. IN ADDITION, THE PRESSURE TEST IS FOLLOWED BY A VISUAL INSPECTION OF EACH CHAMBER. OUR USER INSTRUCTIONS THAT ACCOMPANY THE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER STATE THE FOLLOWING: - DO NOT SOAK, WASH, STERILIZE, OR REUSE THIS PRODUCT. AVOID CONTACT WITH CHEMICALS, CLEANING AGENTS, OR HAND SANITIZERS. - SET APPROPRIATE VENTILATOR ALARMS. - PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT FIVE MR290V HUMIDIFICATION CHAMBERS WERE FOUND TO BE CRACKED DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784365 HIGH FREQUENCY VENTED HUMIDIFICATION CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V

    Patients

    Seq Age Sex Outcome Treatment
    1