BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 3671610 · Received March 10, 2014

    Report

    Report Number
    9611451-2014-00202
    Event Type
    Malfunction
    Date Received
    March 10, 2014
    Date of Event
    February 13, 2014
    Report Date
    February 13, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE FAULTY MANOMETER OF THE RD900AEU NEOPUFF INFANT RESUSCITATOR WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) IN (B)(4) FOR EVALUATION. IT WAS VISUALLY INSPECTED AND PERFORMANCE TESTED BY FITTING INTO A KNOWN GOOD VALVE SYSTEM AND TESTED BASED ON THE NEOPUFF TECHNICAL MANUAL. IN ADDITION, THE MANOMETER WAS TESTED FOR THE ACCURACY OF ITS PRESSURE READINGS BY APPLYING TEST PRESSURES IN 5CM H2O INCREMENTS UNTIL A MAXIMUM OF 71CM H2O. OUR ANALYSIS IS ALSO BASED ON THE SERVICE REPORT PROVIDED BY FPH SERVICE CENTER IN IRVINE, CALIFORNIA. RESULTS: THE SERVICE REPORT SPECIFIED THAT THE TOP PLUG SET OF THE RD900 UNIT WAS MISSING. PERFORMANCE TEST REVEALED THAT THE MANOMETER WAS OUT OF SPECIFICATION. PRESSURE TEST ALSO INDICATED THAT THE ACTUAL PRESSURE DELIVERED WAS LOWER THAN WHAT WAS INDICATED ON THE SUBJECT MANOMETER. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT NUMBER 070815. CONCLUSION: 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. IT MUST BE NOTED THAT THE SUBJECT NEOPUFF HAD BEEN IN SERVICE FOR ALMOST SEVEN YEARS. ALL NEOPUFF UNITS, INCLUDING THE MANOMETERS, ARE VISUALLY INSPECTED FOR ANY DEFECTS OR MISSING COMPONENTS AND PERFORMANCE TESTED FOR FUNCTIONALITY PRIOR TO LEAVING THE PRODUCTION LINE. THOSE THAT FAIL ARE REJECTED. THIS SUSGGGESTS THE THE PLUG SET WAS LOST AFTER THE SUBJECT NEOPUFF UNIT WAS RELEASED FOR DISTRIBUTION. THE DAMAGE TO THE MANOMETER IS MOST LIKELY CAUSED BY SIGNIFICANT IMPACT. 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". THE DEFECTIVE MANOMETER AND MISSING PLUG SET WERE REPLACED AT THE FPH SERVICE CENTRE, AND THE SUBJECT NEOPUFF WAS RETURNED TO THE HEALTHCARE FACILITY AFTER PASSING THE PERFORMANCE CHECKS SPECIFIED IN THE NEOPUFF TECHNICAL MANUAL.

    Additional Manufacturer Narrative · 1

    (B)(4). THE FAULTY MANOMETER OF AN RD900AEU NEOPUFF INFANT RESUSCITATOR IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE COMPLETED OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE MANOMETER OF AN RD900AEU NEOPUFF INFANT RESUSCITATOR WAS NOT PROVIDING ACCURATE READING. THIS WAS OBSERVED DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE MANOMETER OF AN RD900AEU NEOPUFF INFANT RESUSCITATOR WAS NOT PROVIDING ACCURATE READING. THIS WAS OBSERVED DURING US. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142774 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LIMITED RD900AEU

    Patients

    Seq Age Sex Outcome Treatment
    1