BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 2377495 · Received December 15, 2011

    Report

    Report Number
    9611451-2011-00790
    Event Type
    Malfunction
    Date Received
    December 15, 2011
    Date of Event
    November 16, 2011
    Report Date
    November 18, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT MR290V CHAMBER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) IN (B)(4) AND WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED A 1.5MM HOLE IN THE BASE OF THE CHAMBER. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 110428. CONCLUSION: THE SUSTAINED HOLE TO THE BASE OF THE CHAMBER INDICATES THAT IT WAS PUNCTURED WITH A SHARP OBJECT. ALL MR290 CHAMBERS ARE PRESSURE TESTED PRIOR TO DISTRIBUTION. ANY CHAMBER WHICH DOES NOT PASS THE PRESSURE TEST IS DISCARDED. THE SUBJECT MR290 CHAMBER WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. THIS SUGGESTS THAT IT WAS PUNCTURED POST PRODUCTION. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO OUR DISTRIBUTOR THAT WATER LEAKED FROM THE BASE OF AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER. THIS WAS NOTICED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V 110428

    Patients

    Seq Age Sex Outcome Treatment
    1