BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 5345833 · Received January 5, 2016

    Report

    Report Number
    9611451-2016-00003
    Event Type
    Malfunction
    Date Received
    January 5, 2016
    Date of Event
    December 7, 2015
    Report Date
    December 7, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE CURRENTLY IN THE PROCESS OF OBTAINING THE COMPLAINT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER FROM THE HEALTHCARE FACILITY. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE RECEIVED THE COMPLAINT DEVICE AND COMPLETED OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS RETURNED TO FPH IN (B)(4) AND WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED THAT THE RETURNED CHAMBER SUSTAINED CRACK AROUND THE BASE OF THE DOME, STRETCHING FROM ONE OF THE PORTS TO THE BAFFLE AREA. THERE WAS ALSO A CRACK AROUND THE OTHER PORT, AT THE TOP OF THE CHAMBER DOME. RESIDUE AND SMEARED PRINT WERE ALSO OBSERVED ON DIFFERENT PARTS OF THE CHAMBER DOME. A LOT CHECK REVEALED ONE OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 150623. CONCLUSION: THE NATURE OF THE CRACKING, RESIDUE AND SMEARED PRINTS SUGGEST THAT THE DAMAGE WAS CAUSED BY THE CHAMBER COMING INTO CONTACT WITH A SOLUTION CONTAINING ETHANOL/ALCOHOL, WHICH HAS RESULTED IN ENVIRONMENTAL STRESS CRACKING OF THE CHAMBER DOME. EVERY MR290 CHAMBER IS PRESSURE TESTED TO 200 CMH2O 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."; "MAXIMUM OPERATING PRESSURE: 8 KPA."

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS "NOT DENSE" AND FOUND LEAKING DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN AUSTRIA REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS "NOT DENSE" AND FOUND LEAKING DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3735 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V 150623

    Patients

    Seq Age Sex Outcome Treatment
    1