BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 2962865 · Received February 15, 2013

    Report

    Report Number
    9611451-2013-00102
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Report Date
    January 18, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT MR290 DEVICE WAS VISUALLY INSPECTED AND CONNECTED TO A WATER BAG 3 DIFFERENT TIMES TO CHECK FOR LEAKS. RESULTS: VISUAL INSPECTION REVEALED NO DAMAGE ON THE CHAMBER DOME OR BASE. IN ALL 3 TESTS WITH THE WATER BAG, THE WATER STOPPED FILLING THE CHAMBER AT 4MM BELOW THE MAXIMUM FILL LINE. THE FLOAT SYSTEM OPERATED CORRECTLY AND THE CHAMBER WAS WITHIN SPECIFICATION. A LOT CHECK REVEALED NO OTHER COMPLAINT OF THIS TYPE FOR LOT NUMBER 120830. CONCLUSION: NO FAULT WAS FOUND ON THE COMPLAINT MR290 CHAMBER. OVERFILLING IS CAUSED BY BOTH THE PRIMARY AND SECONDARY FLOAT MECHANISMS IN THE MR290 CHAMBER BEING DISABLED. IMPACT DAMAGE CAN LEAD TO MISALIGNMENT AND SUBSEQUENT JAMMING OF THE VALVE FLOAT MECHANISM ALLOWING WATER TO FILL THE CHAMBER UNIMPEDED AND PREVENTING FLOAT OPERATION. THE MR290 CHAMBER USER INSTRUCTIONS INCLUDES A WARNING TO NOT USE THE CHAMBER IF IT HAS BEEN DROPPED. FOLLOWING PRODUCTION, THE FLOAT MECHANISM OF EVERY MR290 CHAMBER IS PERFORMANCE TESTED AND THOSE THAT FAIL ARE REJECTED. OUR USER INSTRUCTIONS THAT ACCOMPANY THE MR290 CHAMBER INDICATE IN PICTORIAL FORM THE MAXIMUM FILL LINE AND ADVISE THE USER TO REPLACE THE CHAMBER SHOULD THE WATER LEVEL EXCEED THE MAXIMUM FILL LINE (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT MR290 DEVICE IS IN TRANSIT TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT OF THE COMPLAINT DEVICE AND COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER AND PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT WATER WAS FILLING "UNCONTROLLABLY" INTO AN MR290 AUTOFEED HUMIDIFICATION CHAMBER. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER AND PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT WATER WAS FILLING "UNCONTROLLABLY" INTO AN MR290 AUTOFEED HUMIDIFICATION CHAMBER. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67247 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 120830

    Patients

    Seq Age Sex Outcome Treatment
    1