BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REUSABLE HUMIDIFICATION CHAMBER

    MDR report key: 5892699 · Received August 21, 2016

    Report

    Report Number
    9611451-2016-21872
    Event Type
    Malfunction
    Date Received
    August 21, 2016
    Date of Event
    July 28, 2016
    Report Date
    July 28, 2016
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K913368
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT MR370 REUSABLE HUMIDIFICATION CHAMBER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) IN (B)(4) FOR INSPECTION. IT WAS VISUALLY INSPECTED AND PRESSURE TESTED. IT WAS CHECKED IN A WATER BATH WITH THE OUTLET PORT OCCLUDED AND PRESSURIZED TO 200CMH2O. RESULTS: VISUAL INSPECTION REVEALED THAT THE RETURNED MR370 CHAMBER WAS CRACKED AT THE BASE OF THE GAS OUTLET PORT. DURING PRESSURE TESTING, AIR BUBBLES WERE FOUND COMING OUT FROM THAT CRACK. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 130416. CONCLUSION: WE ARE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE REPORTED FAULT. ALL MR370 CHAMBERS ARE VISUALLY INSPECTED BEFORE LEAVING THE PRODUCTION LINE AND THOSE THAT FAIL ARE REJECTED. THE SUBJECT MR370 CHAMBER WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. OUR USER INSTRUCTIONS THAT ACCOMPANY THE MR370 REUSABLE HUMIDIFICATION CHAMBER STATE THE FOLLOWING: "MAXIMUM OPERATING PRESSURE: 20 KPA." "WARNING: THE FOLLOWING SOLUTIONS SHOULD BE AVOIDED AS THEY MAY CAUSE THE CHAMBER TO CRACK - KETONES, FORMALDEHYDE, CHLORINATED HYDROCARBONS, HYPOCHLORITE, INORGANIC ACIDS, AROMATIC HYDROCARBONS, PHENOL (>5%)." "TO PREVENT CRACKING, ENSURE THAT THE WATER INLET PORT PLUG, AND ANY OTHER REUSABLE COMPONENTS, ARE DISCONNECTED FROM THE CHAMBER BEFORE CLEANING."

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT MR370 REUSABLE HUMIDIFICATION CHAMBER IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE COMPLETED OUR INVESTIGATION.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED THAT AN MR370 REUSABLE HUMIDIFICATION CHAMBER FAILED THE VENTILATOR LEAK TEST AS THE OUTLET PORT WAS CRACKED. THIS WAS OBSERVED BEFORE USE ON A PATIENT.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED THAT AN MR370 REUSABLE HUMIDIFICATION CHAMBER FAILED THE VENTILATOR LEAK TEST AS THE OUTLET PORT WAS CRACKED. THIS WAS OBSERVED BEFORE USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544531 REUSABLE HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR370 130416

    Patients

    Seq Age Sex Outcome Treatment
    1