BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIFIT HC407 NASAL MASK

    MDR report key: 1894541 · Received November 9, 2010

    Report

    Report Number
    9611451-2010-00647
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Report Date
    October 11, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FISHER & PAYKEL HEALTHCARE CONDUCTED A RECALL ON ALL TAB DESIGNED CONNECTORS FOR CPAP MASKS IN 2006. THE RECALL WAS INITIATED IN (B)(6) ON 21 NOVEMBER 2006 ((B)(4)). THE RECALL WAS COMPLETED BY FISHER & PAYKEL HEALTHCARE AND WAS CLOSED BY THE (B)(6) IN AUGUST 2007. THE RECALL WAS INITIATED IN THE UNITED STATES ON 29 NOVEMBER 2006 ((B)(4)). ALL PRODUCTS MANUFACTURED SINCE APRIL 2006 FEATURES A REDESIGNED CONNECTOR THAT REMOVES THE LOCKING TABS AND WAS NOT SUBJECT TO THIS RECALL. THE PATIENT ADVISED THAT HE RECEIVED A REPLACEMENT MASK WITH THE REDESIGNED ELBOW CONNECTOR.

    Description of Event or Problem · 1

    A PATIENT IN (B)(6) REPORTED THAT "SOME TIME BACK A PIECE BROKE OFF OF THE [HC407 NASAL MASK] ELBOW FIXING WHICH I INHALED". THE PATIENT DID NOT REPORT ANY HEALTH CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIFIT HC407 NASAL MASK BYG BYG FISHER & PAYKEL HEALTHCARE LIMITED HC407A NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1