BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REUSABLE INFANT Y-PIECE

    MDR report key: 837506 · Received February 21, 2007

    Report

    Report Number
    9611451-2007-00038
    Event Type
    Malfunction
    Date Received
    February 21, 2007
    Report Date
    January 19, 2007
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZO
    PMA / PMN Number
    K913368
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    METHODS: NO INFO TO DATE. RESULTS: INVESTIGATION STILL UNDERWAY, NO RESULTS TO DATE. CONCLUSIONS: NO CONCLUSION CAN BE MADE AT THIS TIME. THE DEVICE IS REUSABLE, HOWEVER, WE DO NOT KNOW WHETHER THE PROBLEM WAS DISCOVERED IN USE. ADD'L LOT NUMBER IS 051018.

    Description of Event or Problem · 1

    A HOSP IN A FOREIGN COUNTRY REPORTED THAT THE PLASTIC PART OF THE 900MR145 INFANT Y-PIECE WAS DAMAGED AND BROKEN. ACCORDING TO THE HOSP, THE CLEANING OF THE 900MR145 INTANT Y-PIECE AT 75 DEGREES CELSIUS AND SUBSEQUENT STERILIZATION, AT 55 DEGREES CELSIUS USING ETHYLENE OXIDE GAS STERILIZING COULD HAVE BEEN A CONTRIBUTORY CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REUSABLE INFANT Y-PIECE * BZO FISHER & PAYKEL HEALTHCARE LTD 900MR145 050920

    Patients

    Seq Age Sex Outcome Treatment
    1 *