BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 3333205 · Received September 9, 2013

    Report

    Report Number
    9611451-2013-00670
    Event Type
    Malfunction
    Date Received
    September 9, 2013
    Report Date
    August 14, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RD900AGU NEOPUFF INFANT RESUSCITATOR WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) IN (B)(4) FOR INSPECTION. IT WAS VISUALLY INSPECTED AND PERFORMANCE TESTED AS PER NEOPUFF TECHNICAL MANUAL. RESULTS: INITIAL PERFORMANCE CHECK CONDUCTED AT FPH SERVICE CENTER IN GERMANY SHOWED THAT THE MANOMETER WAS NOT INDICATING PRESSURE IN EXCESS OF 38CMH2O. NO PHYSICAL DAMAGE WAS OBSERVED TO THE RETURNED NEOPUFF UNIT WHEN IT WAS VISUALLY INSPECTED AT FPH IN (B)(4). WHEN A TEST MANOMETER WAS INSERTED INTO THE NEOPUFF UNIT, NO FAULT WAS FOUND WITH THE VALVE SYSTEM. INTERNAL INSPECTION OF THE DEFECTIVE MANOMETER REVEALED THAT THERE WAS AN OBSTRUCTION IN ONE OF THE COGS/GEARS, CAUSING THE REPORTED FAULT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 130307. CONCLUSION: THE FAULT REPORTED BY THE HEALTHCARE FACILITY IS MOST LIKELY DUE TO THE OBSTRUCTION IN THE MANOMETER'S INTERNAL MECHANISM, IMPEDING THE MOVEMENT OF THE MANOMETER NEEDLE; HOWEVER, WE WERE UNABLE TO DETERMINE WHERE THE OBSTRUCTION CAME FROM. 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. ALL NEOPUFF UNITS ARE VISUALLY INSPECTED AND PERFORMANCE TESTED PRIOR TO LEAVING THE PRODUCTION LINE, AND THOSE THAT FAIL ARE QUARANTINED FOR FURTHER INVESTIGATION. THE PRODUCTION TEST OF THE SUBJECT NEOPUFF UNIT SHOWED THAT IT PASSED THE REQUIRED TEST AT THE TIME OF MANUFACTURE. THIS SUGGESTS THAT THE MANOMETER WAS DAMAGED AFTER THE SUBJECT NEOPUFF UNIT WAS RELEASED FOR DISTRIBUTION. THE NEOPUFF TECHNICAL MANUAL WARNS AGAINST DROPPING THE NEOPUFF OR SUBJECTING IT TO IMPACT DAMAGE WHICH MAY CAUSE THE UNIT TO OPERATE INCORRECTLY. IF THE NEOPUFF IS SUSPECTED TO HAVE BEEN DAMAGED, THE MANOMETER AND VALVE SYSTEM SHOULD BE PERFORMANCE TESTED. 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". 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". (B)(4).

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE MAXIMUM PRESSURE RELIEF VALVE OF THEIR NEWLY PURCHASED RD900AGU NEOPUFF INFANT RESUSCITATOR COULD NOT BE ADJUSTED. THIS WAS OBSERVED DURING INITIAL INSPECTION OF THE DEVICE AT THEIR FACILITY, BEFORE USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450017 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LIMITED RD900AGU

    Patients

    Seq Age Sex Outcome Treatment
    1