BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 3120871 · Received May 20, 2013

    Report

    Report Number
    9611451-2013-00403
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    March 18, 2013
    Report Date
    April 22, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT NEOPUFF INFANT RESUSCITATOR WAS RETURNED TO OUR REGIONAL FACILITY IN (B)(4). IT HAS BEEN VISUALLY INSPECTED AND PERFORMANCE TESTED BASED ON THE NEOPUFF TECHNICAL MANUAL BY A TRAINED FISHER & PAYKEL HEALTHCARE SERVICE ENGINEER. RESULTS: THE VISUAL INSPECTION OF THE COMPLAINT NEOPUFF IDENTIFIED THAT THE MAXIMUM PRESSURE RELIEF CAP AND A PLUG SET WAS MISSING. THE MANOMETER WAS OBSERVED TO BE FAULTY. DURING THE PERFORMANCE CHECK, THE MAXIMUM PRESSURE RELIEF VALVE WAS FOUND TO BE INOPERABLE. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THIS LOT NUMBER. CONCLUSION: THE DAMAGE TO THE MAXIMUM PRESSURE RELIEF VALVE IS MOST LIKELY TO HAVE BEEN CAUSED BY PHYSICAL DAMAGE DUE TO SIGNIFICANT IMPACT. THE NEOPUFF IS A PORTABLE, REUSABLE DEVICE USED TO ASSIST IN THE DELIVERY OF RESPIRATORY BREATHS TO INFANTS UNTIL ADEQUATE SPONTANEOUS BREATHING OCCURS. BEING A PORTABLE DEVICE, THE NEOPUFF CAN BE SUSCEPTIBLE TO IMPACT DAMAGE, FOR INSTANCE WHEN ACCIDENTALLY DROPPED OR SUBJECTED TO CONSIDERABLE EXTERNAL FORCE. THE NEOPUFF TECHNICAL MANUAL STATES THE FOLLOWING: "DROPPING THE NEOPUFF/PERIVENT INFANT RESUSCITATOR OR OTHER SIMILAR FORMS OF IMPACT MAY CAUSE DAMAGE RESULTING IN INCORRECT OPERATION OF THE UNIT. IF YOU SUSPECT DAMAGE TO HAVE OCCURRED, PLEASE PERFORM CHECKS AS OUTLINED [IN THE MANUAL] BEFORE CONNECTION TO A PATIENT" THE NEOPUFF TECHNICAL MANUAL ADVISES THAT "THE INTEGRITY OF THE SYSTEM AND MANOMETER SHOULD BE CHECKED PRIOR TO FIRST USE, ANNUALLY AND AFTER SERVICING" BY A QUALIFIED PERSONNEL OR AN AUTHORIZED FISHER & PAYKEL HEALTHCARE REPRESENTATIVE USING THE TESTS DESCRIBED IN THE MANUAL. IN ADDITION THE NEOPUFF USER INSTRUCTIONS STATE THAT THE USER SHOULD "CHECK MANOMETER READS ZERO WITH NO GAS FLOW" AND CHECK THE PRESSURE SETTINGS "PRIOR TO EVERY USE OF THE NEOPUFF". THE MISSING PLUG SET, FASCIA AND VALVE SYSTEM HAVE BEEN REPLACED AND THE NEOPUFF HAS BEEN RETURNED TO THE HEALTHCARE FACILITY AFTER PASSING ALL PERFORMANCE AND SAFETY CHECKS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE "PRESSURE RELEASE VALVE" OF AN RD900 NEOPUFF INFANT RESUSCITATOR IS "BROKEN". NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222143 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LTD RD900AEU 060228

    Patients

    Seq Age Sex Outcome Treatment
    1