BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 1930850 · Received December 16, 2010

    Report

    Report Number
    9611451-2010-00754
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 18, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE RETURNED NEOPUFF WAS VISUALLY INSPECTED FOR DAMAGE AND THE MANOMETER WAS TESTED IN ACCORDANCE WITH THE APPLICABLE MANUALS. RESULTS: THERE WAS NO EVIDENCE OF PHYSICAL DAMAGE TO THE NEOPUFF. THE MANOMETER NEEDLE WAS SET TO ZERO PER THE MANUAL. THE CALIBRATED MANOMETER FUNCTIONED PROPERLY DURING TESTING. CONCLUSION: THE NEOPUFF OPERATING MANUAL INSTRUCTS THE USER TO CARRY OUT A SET-UP PROCEDURE "PRIOR TO EVERY USE OF THE NEOPUFF TO ENSURE THAT THE DEVICE IS FUNCTIONING CORRECTLY". THE SET-UP PROCEDURE STATES THE USER MUST "CHECK MANOMETER READS ZERO WITH NO GAS FLOW. IF NOT, THE MANOMETER REQUIRES CALIBRATION" PER THE TECHNICAL MANUAL. WHEN THE MANOMETER HAD BEEN CALIBRATED, IT OPERATED PROPERLY AND WAS GIVING ACCURATE READINGS WHEN COMPARED TO A PRECISION PRESSURE TRANSDUCER. NO FAULT WAS FOUND WITH THE COMPLAINT DEVICE. FISHER & PAYKEL HEALTHCARE ZEROES THE NEOPUFF MANOMETERS DURING PRODUCTION AND TESTS EACH MANOMETER FOR ACCURACY. AS THE MANOMETER NEEDLE WAS NOT READING ZERO WHEN THE DEVICE WAS RECEIVED, IT IS LIKELY THAT THE DEVICE WAS SUBJECTED TO A SUBSTANTIAL IMPACT DURING TRANSPORT OR SET-UP. AS THE DEVICE HAD BEEN RETURNED TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION, THE HOSPITAL HAD BEEN PROVIDED WITH A NEW DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT NEOPUFF HAS NOT YET BEEN RECEIVED BY FISHER & PAYKEL HEALTHCARE FOR EVALUATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT OF THE DEVICE AND COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT THE MANOMETER NEEDLE ON AN RD900 NEOPUFF INFANT RESUSCITATOR WAS STICKING. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT THE MANOMETER NEEDLE ON AN RD900 NEOPUFF INFANT RESUSCITATOR WAS STICKING. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEOPUFF INFANT RESUSCITATOR INFANT RESUSCITATOR BTL FISHER & PAYKEL HEALTHCARE RD900AEU 100802

    Patients

    Seq Age Sex Outcome Treatment
    1