BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REUSABLE HUMIDIFICATION CHAMBER

    MDR report key: 5440034 · Received February 16, 2016

    Report

    Report Number
    9611451-2016-00055
    Event Type
    Malfunction
    Date Received
    February 16, 2016
    Date of Event
    January 18, 2016
    Report Date
    January 18, 2016
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    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). CORRECTION: THE WRONG PS NUMBER WAS REFERENCED IN THE ORIGINAL REPORT. (B)(4). METHOD: THE COMPLAINT MR370 ADULT REUSABLE CHAMBER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) AND WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED THAT THE CHAMBER DOME WAS NOT FULLY FITTED TO THE CHAMBER BASE. NO PHYSICAL DAMAGE TO THE CHAMBER WAS OBSERVED. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 150603. CONCLUSION: IT IS LIKELY THAT OPERATOR ERROR RESULTED IN THE CHAMBER DOME NOT FITTING PROPERLY TO THE CHAMBER BASE. THERE ARE STANDARD PROCEDURES (SOPS) IN PLACE TO ASSIST OPERATORS ON THE PRODUCTION LINE TO CORRECTLY ASSEMBLE THE CHAMBER DOME TO THE CHAMBER BASE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT MR370 ADULT REUSABLE CHAMBER IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (FPH) REPRESENTATIVE THAT THE DOME OF A MR370 REUSABLE HUMIDIFICATION CHAMBER WAS NOT FULLY CONNECTED TO THE CHAMBER BASE. THIS WAS DISCOVERED BEFORE PATIENT USE.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (FPH) REPRESENTATIVE THAT THE DOME OF A MR370 REUSABLE HUMIDIFICATION CHAMBER WAS NOT FULLY CONNECTED TO THE CHAMBER BASE. THIS WAS DISCOVERED BEFORE PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96531 REUSABLE HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LTD MR370 150603

    Patients

    Seq Age Sex Outcome Treatment
    1