BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BI-LEVEL/CPAP INSPIRATORY HEATED CIRCUIT

    MDR report key: 2364151 · Received December 8, 2011

    Report

    Report Number
    9611451-2011-00766
    Event Type
    Malfunction
    Date Received
    December 8, 2011
    Date of Event
    November 10, 2011
    Report Date
    November 11, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RT219 BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) AND VISUALLY INSPECTED. RESULTS: THE COMPLAINT DEVICE WAS RETURNED WITH THE HEATERWIRE PLUG ASSEMBLED TO THE INSPIRATORY ELBOW. NO DAMAGED TO THE HEATERWIRE PLUG OR INSPIRATORY ELBOW WAS FOUND. THE HEATERWIRE WAS DISTRIBUTED EVENLY IN THE INSPIRATORY LIMB AND SHOWED NO SIGNS OF BEING PULLED OUT OF THE INSPIRATORY LIMB. A LOT CHECK REVEALED NO OTHER COMPLAINT OF THIS TYPE FOR LOT NUMBER 110818. CONCLUSION: WE WERE UNABLE TO REPLICATE THE FAULT REPORTED BY THE HOSPITAL AS A HEATERWIRE ADAPTOR WAS CONNECTED TO THE HEATERWIRE PLUG ON THE COMPLAINT DEVICE, AND THE ADAPTOR WAS ABLE TO BE REMOVED WITHOUT THE HEATERWIRE PLUG BEING DISASSEMBLED FROM THE INSPIRATORY ELBOW OF THE COMPLAINT DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE CURRENTLY ENDEAVOURING TO OBTAIN MORE INFORMATION REGARDING THE COMPLAINT DEVICE AND THE DEVICE RETURN. WE WILL PROVIDE A FOLLOW UP REPORT UPON RECEIPT OF THE DEVICES AND COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE Y-PIECE OF AN RT219 ADULT BI-LEVEL/CPAP BREATHING CIRCUIT WAS DISCONNECTED AS THE HEATER WIRE ADAPTER WAS PULLED FROM THE Y-PIECE. THIS WAS REPORTED PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE Y-PIECE OF AN RT219 ADULT BI-LEVEL/CPAP BREATHING CIRCUIT WAS DISCONNECTED AS THE HEATER WIRE ADAPTER WAS PULLED FROM THE Y-PIECE. THIS WAS REPORTED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BI-LEVEL/CPAP INSPIRATORY HEATED CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT219 110818

    Patients

    Seq Age Sex Outcome Treatment
    1