BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 8360629 · Received February 21, 2019

    Report

    Report Number
    9611451-2019-00148
    Event Type
    Malfunction
    Date Received
    February 21, 2019
    Date of Event
    December 20, 2018
    Report Date
    December 21, 2018
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: BOTH OF THE COMPLAINT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS (LOT 180725, DEVICE MF DATE: 25 JUL 2018; LOT 180731, DEVICE MF DATE: 31 JUL 2018) WERE RETURNED TO F&P IN (B)(4) AND WERE VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED THAT ONE RETURNED CHAMBER (LOT 180725) HAD SUSTAINED MULTIPLE VERTICAL CRACKS AROUND THE BASE OF THE DOME. THIS CHAMBER DID NOT LEAK WHEN FILLED WITH WATER. THE SECOND RETURNED CHAMBER (LOT 180731) WAS FOUND TO HAVE ONE HORIZONTAL CRACK LINE AROUND THE BASE OF THE CHAMBER. WHEN FILLED WITH WATER, A LEAK WAS OBSERVED FROM THIS UNIT. CONCLUSION: FROM THE PROVIDED INFORMATION AND VISUAL INSPECTION, IT WAS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE CRACKING OBSERVED IN EITHER COMPLAINT DEVICE. 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. IN ADDITION, THE PRESSURE TEST IS FOLLOWED BY A VISUAL INSPECTION OF EACH CHAMBER. ANY CHAMBER WHICH FAILS EITHER OF THESE TESTS IS REJECTED. THE CHAMBER WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. MOREOVER, THE HEALTHCARE FACILITY REPORTED THAT THE DAMAGE OCCURRED DURING USE, WHICH SUGGESTS THAT THE SUBJECT MR290 CHAMBER BECAME DAMAGED AFTER IT WAS RELEASED FOR DISTRIBUTION. 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." - "MAXIMUM OPERATING PRESSURE: 8 KPA.".

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED VIA A FISHER & PAYKEL (F&P) FIELD REPRESENTATIVE THAT TWO MR290V VENTILATED HUMIDIFICATION CHAMBERS RAN OUT OF WATER SUDDENLY DURING USE. NO FURTHER INFORMATION WAS PROVIDED. NO PATIENT CONSEQUENCE WAS REPORTED. THE COMPLAINT DEVICES WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) WHERE, UPON INVESTIGATION (ON 23 JAN 2019), IT WAS DISCOVERED THAT BOTH OF THE MR290V CHAMBERS WERE CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150078 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LTD MR290V SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1