BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 2028860 · Received March 24, 2011

    Report

    Report Number
    9611451-2011-00192
    Event Type
    Malfunction
    Date Received
    March 24, 2011
    Date of Event
    September 29, 2011
    Report Date
    February 24, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE HAS RECENTLY BEEN RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE RETURNED NEOPUFF WAS VISUALLY INSPECTED FOR DAMAGE. RESULTS: TWO CRACKS WERE FOUND ON THE FRONT FASCIA OF THE NEOPUFF. THE UPPER AND LOWER END CAPS WERE ALSO FOUND TO BE CRACKED. THE TUBE THAT CONNECTS THE CENTER MANIFOLD PORT TO THE MANOMETER WAS CUT AT THE PORT END. THE CUT IS NOT SMOOTH AND THE TUBE AROND THE CUT WAS COMPRESSED. A 360-DEGREE CRACK WAS FOUND ALONG THE CIRCUMFERENCE OF THE MANIFOLD. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 070219. CONCLUSION: THE CUT IN THE TUBE APPEARS TO HAVE BEEN MADE INTENTIONALLY USING A TOOL AS THE TUBE IS COMPRESSED AROUND THE CUT. IT IS LIKELY THAT THE MANIFOLD CRACKED DUE TO STRESS WHEN THE TUBING WAS CUT. THE CUT WOULD HAVE CAUSED THE FAULT REPORTED BY THE CUSTOMER HOWEVER IT IS NOT KNOWN WHY THE TUBE WAS CUT. THE NEOPUFF USER INSTRUCTIONS REQUIRE THAT THE NEOPUFF BE TESTED BY QUALIFIED PERSONNEL OR AN AUTHORIZED FISHER & PAYKEL HEALTHCARE REPRESENTATIVE PRIOR TO EACH USE TO ENSURE FUNCTIONALITY. THE SET-UP PROCEDURE STATES THE USER MUST CHECK THE SETTINGS BY TESTING THE PRESSURE OUTPUT FROM THE NEOPUFF AT THE DESIRED FLOW RATE "PRIOR TO EVERY USE OF THE NEOPUFF TO ENSURE THAT THE DEVICE IS FUNCTIONING CORRECTLY".

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN RD900 NEOPUFF INFANT RESUSCITATOR DID NOT PASS THE PERFORMANCE CHECK. THE PRESSURE OUTPUT AT 6 LPM FLOW WAS TOO LOW. THE PERFORMANCE CHECK WAS CARRIED OUT PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN RD900 NEOPUFF INFANT RESUSCITATOR DID NOT PASS THE PERFORMANCE CHECK. THE PRESSURE OUTPUT AT 6LPM FLOW WAS TOO LOW. THE PERFORMANCE CHECK WAS CARRIED OUT PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LIMITED RD900 070219

    Patients

    Seq Age Sex Outcome Treatment
    1