BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BI-LEVEL/CPAP ADULT BREATHING CIRCUIT

    MDR report key: 2223805 · Received August 25, 2011

    Report

    Report Number
    9611451-2011-00519
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Report Date
    July 27, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT RT139 ADULT BREATHING CIRCUIT KIT WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. OUR INVESTIGATION IS BASED ON PHOTOGRAPHS SUPPLIED BY THE CUSTOMER. THE CUSTOMER HAD REPORTED THAT THE RT139 CIRCUIT KIT WAS CONTAINED IN ITS SEALED BAG BUT WAS NOT ASSEMBLED, HOWEVER OUR VISUAL INSPECTION OF THE SUPPLIED PHOTOGRAPHS REVEALED THAT THE CIRCUIT APPEARED NORMAL AND WAS CORRECTLY ASSEMBLED. (B)(4). WE COULD FIND NO FAULT WITH THE COMPLAINT DEVICE, BASED ON THE SUPPLIED PHOTOGRAPHS. ALL BREATHING CIRCUITS ARE ASSEMBLED AND PRESSURE TESTED PRIOR TO PACKING AND ANY THAT FAIL ARE REJECTED.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(4) REPORTED THAT AN RT134 ADULT BREATHING CIRCUIT WAS RECEIVED UNASSEMBLED IN ITS PACKAGING. THIS WAS FOUND DURING AN INCOMING GOODS INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BI-LEVEL/CPAP ADULT BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT139 110322

    Patients

    Seq Age Sex Outcome Treatment
    1