BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYGEN/AIR GAS SUPPLY MODULE

    MDR report key: 1584642 · Received January 20, 2010

    Report

    Report Number
    9611451-2010-00018
    Event Type
    Malfunction
    Date Received
    January 20, 2010
    Date of Event
    December 21, 2009
    Report Date
    December 22, 2009
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    FMT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT 900IW104 IS NOT SOLD IN THE US, BUT IS SIMILAR TO A PRODUCT THAT IS SOLD IN THE US. THE 510(K) NUMBER FOR THE SIMILAR PRODUCT IS K971695. FISHER & PAYKEL IS CURRENTLY IN THE PROCESS OF OBTAINING FURTHER INFO REGARDING THIS COMPLAINT. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT ONE OF THE GAS REGULATORS FROM A 900IW104 OXYGEN/AIR GAS SUPPLY MODULE WAS LEAKING. NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXYGEN/AIR GAS SUPPLY MODULE FMT FISHER & PAYKEL HEALTHCARE, LTD. 900IW104

    Patients

    Seq Age Sex Outcome Treatment
    1 FISHER & PAYKEL HEALTHCARE IW932AEK COSYCOT INFANT| WARMER