BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FREQUENCY VENTED HUMIDIFICATION CHAMBER

    MDR report key: 5265630 · Received December 3, 2015

    Report

    Report Number
    9611451-2015-00516
    Event Type
    Malfunction
    Date Received
    December 3, 2015
    Date of Event
    November 3, 2015
    Report Date
    November 5, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THREE COMPLAINT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS (DEVICE 1 AND 2: LOT 140401, MANUFACTURED ON 1 APRIL 2014; DEVICE 3: LOT 150413, MANUFACTURED ON 13 APRIL 2015) WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) AND WERE VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED THAT FOR ALL THREE COMPLAINT DEVICES, THE CHAMBER DOME WAS CRACKED. VISUAL INSPECTION OF DEVICE 1 REVEALED A CRACK BELOW THE PORT AND THE PRINTING ON THE DOME WAS OBSERVED TO BE SMEARED. FOR DEVICE 2, VISUAL INSPECTION REVEALED A CRACK BELOW THE PORT AND RESIDUE WAS OBSERVED AROUND THE CRACK. VISUAL INSPECTION OF DEVICE 3 REVEALED A CRACK AROUND THE BASE OF THE CHAMBER DOME. THE CRACK STARTED BLOW THE PORT AND TO THE HINGE BRACKET. RESIDUE WAS OBSERVED AROUND THE CRACK. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 140401 AND ONE OTHER COMPLAINT OF THIS NATURE FOR LOT 150413. CONCLUSION: THE SMEARED PRINT AND 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 HOSPITAL IN (B)(6) REPORTED VIA AN FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT THREE MR290 HUMIDIFICATION CHAMBERS WERE FOUND "DEFECTIVE" DURING USE. FURTHER INFORMATION REVEALED THAT THE CHAMBERS WERE CRACKED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795138 HIGH FREQUENCY VENTED HUMIDIFICATION CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 140401

    Patients

    Seq Age Sex Outcome Treatment
    1