BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 1934801 · Received December 21, 2010

    Report

    Report Number
    9611451-2010-00765
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Report Date
    November 22, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT OF THE DEVICE AND COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE RETURNED COMPLAINT DEVICE WAS VISUALLY INSPECTED. RESULTS: THE VISUAL INSPECTION REVEALED THAT AN INCORRECT LANGUAGE FASCIA HAD BEEN ATTACHED TO THE PANEL OF THE COMPLAINT DEVICE. A (B)(6) FASCIA HAD BEEN SUPPLIED INSTEAD OF AN ENGLISH ONE. THE (B)(6) FASCIA IS LABELED 'PERIVENT' RATHER THAN 'NEOPUFF' AND THE VALVES ARE LABELED AS SYMBOLS INSTEAD OF WORDS. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THIS LOT NUMBER. CONCLUSION: THE NEOPUFF IS A PORTABLE, REUSABLE DEVICE USED TO ASSIST IN THE DELIVERY OF RESPIRATORY BREATHS TO INFANTS UNTIL ADEQUATE SPONTANEOUS BREATHING OCCURS. THE ROOT CAUSE OF THE INCORRECT FASCIA BEING SUPPLIED IS MOST LIKELY OPERATOR ERROR, WITH THE PRODUCTION OPERATOR ATTACHING THE WRONG FASCIA. THE PART NUMBERS OF THE NEOPUFF COMPONENTS, INCLUDING THE FASCIA, ARE CHECKED AGAINST THE BILL OF MATERIALS PRIOR TO LEAVING OUR FACILITY, HOWEVER IN THIS CASE THE MISMATCH WAS NOT NOTED WHEN INSPECTED. THE ATTACHMENT OF THE INCORRECT FASCIA DOES NOT COMPROMISE THE FUNCTIONALITY OF THE DEVICE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT A VALVE ASSEMBLY KIT FOR AN RD900 NEOPUFF INFANT RESUSCITATOR CONTAINED THE INCORRECT FASCIA. THIS WAS FOUND PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT A VALVE ASSEMBLY KIT FOR AN RD900 NEOPUFF INFANT RESUSCITATOR CONTAINED THE INCORRECT FASCIA. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LTD RD900AEU 101026

    Patients

    Seq Age Sex Outcome Treatment
    1