BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY-HEATED BREATHING CIRCUIT

    MDR report key: 1996937 · Received February 20, 2011

    Report

    Report Number
    9611451-2011-00083
    Event Type
    Malfunction
    Date Received
    February 20, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 25, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    REFER TO H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K): THE PRODUCT REFERRED TO IN THE EVENT DESCRIPTION IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT SOLD IN THE USA. THE 510(K) FOR THE SIMILAR PRODUCT IS K983112. THIS COMPLAINT, WHICH WAS REPORTED TO US BY ONE OF THE HOSPITALS IN (B)(6), IS A DUPLICATE OF ANOTHER COMPLAINT THAT WE REPORTED TO FDA ON 01 APRIL 2011. THE MFR. REPORT # FOR THAT SIMILAR COMPLAINT IS 9611451-2011-00211.

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K): THE PRODUCT REFERRED TO IN THE EVENT DESCRIPTION IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT SOLD IN THE USA. THE 510(K) FOR THE SIMILAR PRODUCT IS K983112. THE RT102 ADULT INSPIRATORY-HEATED BREATHING 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 DISTRIBUTOR IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE QUALITY MANAGER THAT A PART OF A TUBE WAS MISSING FROM AN RT102 ADULT INSPIRATORY-HEATED BREATHING CIRCUIT KIT. THIS WAS OBSERVED BEFORE OPENING THE CIRCUIT PACKAGE.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(4) REPORTED TO A FISHER & PAYKEL HEALTHCARE QUALITY MANAGER THAT A PART OF A TUBE WAS MISSING FROM AN RT102 ADULT INSPIRATORY-HEATED BREATHING CIRCUIT KIT. THIS WAS OBSERVED BEFORE OPENING THE CIRCUIT PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT INSPIRATORY-HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED RT102 100301

    Patients

    Seq Age Sex Outcome Treatment
    1