BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADJUSTABLE T-PIECE AND RESUSCITATION CIRCUIT

    MDR report key: 2385395 · Received December 21, 2011

    Report

    Report Number
    9611451-2011-00814
    Event Type
    Malfunction
    Date Received
    December 21, 2011
    Report Date
    December 5, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT 900RD010 DEVICES WERE RETURNED TO FISHER & PAYKEL HEALTHCARE NEW ZEALAND FOR INSPECTION. BOTH CIRCUITS WERE VISUALLY INSPECTED AND PRESSURE TESTED TO CHECK FOR LEAK. RESULTS: BOTH CIRCUITS WERE FOUND TO HAVE HOLES. DEVICE 1 HAD A HOLE APPROXIMATELY 2MM X 4MM LOCATED 1150MM FROM THE T-PIECE END. DEVICE 2 HAD A HOLE APPROXIMATELY 2MM X 3MM LOCATED 960MM FROM THE T-PIECE END. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR LOT NUMBER 110930. CONCLUSION: THIS IS THE ONLY COMPLAINT WE HAVE HAD FOR THIS ISSUE. TESTING OF 900RD010 CIRCUITS ON THE PRODUCTION LINE STARTED ON (B)(4) 2011. THE TWO COMPLAINT 900RD010 CIRCUITS WERE MANUFACTURED BEFORE THIS TESTING WAS INTRODUCED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE IS EN ROUTE TO THE MANUFACTURER. 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 THEY FOUND HOLES IN TWO 900RD010 RESUSCITATION CIRCUITS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(4) REPORTED THAT THEY FOUND HOLES IN TWO 900RD010 RESUSCITATION CIRCUITS. THIS WAS FOUND BEFORE USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADJUSTABLE T-PIECE AND RESUSCITATION CIRCUIT BTL BTL FISHER & PAYKEL HEALTHCARE LTD 900RD010 110930

    Patients

    Seq Age Sex Outcome Treatment
    1