BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BI-LEVEL/CPAP INSPIRATORY HEATED CIRCUIT

    MDR report key: 1848661 · Received September 22, 2010

    Report

    Report Number
    9611451-2010-00565
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Report Date
    August 23, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE CURRENTLY ENDEAVORING TO OBTAIN MORE INFO FROM THE CUSTOMER WITH REGARD TO THE COMPLAINT DEVICE. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: TWO COMPLAINT BREATHING CIRCUIT KITS WERE RECEIVED. ONE HAD LOT NUMBER 091207 AND WAS RETURNED UNSEALED. THE SECOND ONE WAS RETURNED SEALED AND HAD LOT NUMBER 100411. THE COMPLAINT DEVICES WERE VISUALLY INSPECTED. RESULTS: THE VISUAL INSPECTION REVEALED THAT A PRESSURE LINE WAS MISSING FROM BOTH BREATHING CIRCUIT KITS. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR EITHER LOT NUMBERS. CONCLUSION: THE BREATHING CIRCUIT PACKAGE CONSISTS OF A NUMBER OF COMPONENTS GROUPED TOGETHER DURING PRODUCTION. IT IS LIKELY THAT THE PRESSURE LINES WERE OMITTED DURING THE ASSEMBLY PROCESS. OPERATING PROCESS PROCEDURES ARE IN PLACE TO ASSIST THE OPERATORS ON THE PRODUCTION LINE TO CORRECTLY PACK BREATHING CIRCUITS. A PACK CARD DETAILING ALL COMPONENTS REQUIRED IS DISPLAYED AT THE PACKING STATION. EACH COMPLETED CIRCUIT PACK IS THEN WEIGHED TO ENSURE THAT EVERY COMPONENT CIRCUIT PACK IS ACCOUNTED FOR. OUR MONITORING AND TRENDING OF EVENTS INVOLVING MISSING OR WRONG COMPONENTS IN BREATHING CIRCUITS HAS A RATE OF OCCURRENCE OF 45 DEVICES PER MILLION SOLD WORLDWIDE IN THE LAST YEAR TO (B)(6) 2010.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE PRESSURE LINE OF TWO (B)(4) INSPIRATORY HEATED CIRCUIT KITS WERE MISSING. THIS WAS FOUND BEFORE PT USE.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE PRESSURE LINE WAS MISSING FROM TWO (B)(4) INSPIRATORY HEATED CIRCUIT KITS. THIS WAS FOUND BEFORE PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BI-LEVEL/CPAP INSPIRATORY HEATED CIRCUIT BTT FISHER & PAYKEL HEALTHCARE LTD RT219 091207, 100411

    Patients

    Seq Age Sex Outcome Treatment
    1