BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BI-LEVEL/CPAP INSPIRATORY HEATED CIRCUIT

    MDR report key: 1870349 · Received October 5, 2010

    Report

    Report Number
    9611451-2010-00604
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 7, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT219 ADULT BI-LEVEL/CPAP INSPIRATORY HEATED CIRCUIT IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE RECEIVE THE COMPLAINT DEVICE AND HAVE COMPLETED OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT AN RT219 ADULT BI-LEVEL/CPAP INSPIRATORY HEATED CIRCUIT'S "PINS THAT CONNECT HEATER WIRE ADAPTER ARRIVED BENT AND UNABLE TO CONNECT TO PIGTAIL ADAPTER." NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BI-LEVEL/CPAP INSPIRATORY HEATED CIRCUIT BTT FISHER & PAYKEL HEALTHCARE, LTD. RT219 100503

    Patients

    Seq Age Sex Outcome Treatment
    1