BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT HUMIDIFICATION CHAMBER

    MDR report key: 1610140 · Received February 15, 2010

    Report

    Report Number
    9611451-2010-00041
    Event Type
    Malfunction
    Date Received
    February 15, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE SIX (6) COMPLAINT CHAMBERS WERE VISUALLY INSPECTED FOR DAMAGE. RESULTS: ALL SIX (6) OF THE MR210 CHAMBER DOMES WERE CRACKED. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 081201, 080403, 081117 OR 080911. CONCLUSION: ALL CHAMBERS ARE PRESSURE TESTED DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THE CRACKS DEVELOPED POST PRODUCTION, DURING TRANSPORT, STORAGE OR USE. ALL OF THE RETURNED CHAMBERS HAD CRACKS IN THE DOMES, WHICH WOULD HAVE RESULTED IN THE REPORTED CHAMBER LEAKS. THE CRACKS WERE CONSISTENT WITH DAMAGE TO THE CHAMBER DOME CAUSED BY AN EXTERNAL IMPACT OR CRUSHING. (B)(4).

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(4) REPORTED THAT SIX (6) MR210 ADULT HUMIDIFICATION CHAMBERS WERE LEAKING. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT HUMIDIFICATION CHAMBER BTT FISHER & PAYKEL HEALTHCARE, LTD. MR210

    Patients

    Seq Age Sex Outcome Treatment
    1