BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT HUMIDIFICATION CHAMBER

    MDR report key: 1930852 · Received December 16, 2010

    Report

    Report Number
    9611451-2010-00756
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT CHAMBER HAS NOT YET BEEN RECEIVED BY FISHER & PAYKEL HEALTHCARE FOR EVALUATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT OF THE CHAMBER AND COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6).

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER ADDRESS: (B)(6). METHOD: THE RETURNED MR210 HUMIDIFICATION CHAMBER WAS VISUALLY INSPECTED FOR DAMAGE. RESULTS: A CRACK AND IMPACT MARK WERE FOUND NEAR THE BASE OF THE CHAMBER. IN ADDITION, A 2 MILLIMETER LONG HORIZONTAL SCRAPE MARK WAS FOUND ABOVE THE CHAMBER BASE. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 091207. CONCLUSION: ALL MR210 CHAMBERS ARE PRESSURE TESTED AND VISUALLY DURING PRODUCTION. IN ADDITION, THE CHAMBERS ARE VISUALLY INSPECTED PRIOR TO PACKING. THIS SUGGESTS THE CRACKS DEVELOPED POST PRODUCTION, DURING TRANSPORT OR STORAGE. THE DAMAGE IS CONSISTENT WITH DAMAGE CAUSED BY IMPACT. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT AN MR210 HUMIDIFICATION HAD A CRACK WHICH CAUSED WATER TO LEAK OUT WHEN FILLED. THE CHAMBER LEAK WAS OBSERVED BY THE HOSPITAL PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT AN MR210 HUMIDIFICATION HAD A CRACK WHICH CAUSED WATER TO LEAK OUT WHEN FILLED. THE CHAMBER LEAK WAS OBSERVED BY THE HOSPITAL PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT AN MR210 HUMIDIFICATION HAD A CRACK WHICH CAUSED WATER TO LEAK OUT WHEN FILLED. THE CHAMBER LEAK WAS OBSERVED BY THE HOSPITAL PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR210X 091207

    Patients

    Seq Age Sex Outcome Treatment
    1