BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 6015779 · Received October 10, 2016

    Report

    Report Number
    9611451-2016-00643
    Event Type
    Malfunction
    Date Received
    October 10, 2016
    Report Date
    September 13, 2016
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SERIAL NUMBER: (B)(4), MANUFACTURING DATE: 01/28/2009, QUANTITY AFFECTED: 1; (B)(4), 01/24/2009, 1. THE TWO COMPLAINT RD900AEU NEOPUFF INFANT RESUSCITATORS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE SERVICE CENTER IN (B)(4) FOR INSPECTION AND SERVICING. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE COMPLETED OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). SERIAL NUMBER LOT NUMBER: MANUFACTURING DATE: QUANTITY: AFFECTED: (B)(4), 090128, 01/28/2009, 1. (B)(4), 090124, 01/24/2009, 1. METHOD: THE COMPLAINT RD900AEU NEOPUFF INFANT RESUSCITATORS WERE RETURNED TO FPH SERVICE CENTER IN (B)(4), WHERE THE UNITS WERE INSPECTED BY A TRAINED FPH SERVICE ENGINEER. THE MANOMETER OF THE NEOPUFF UNIT WITH SN (B)(4) WAS RETURNED TO FPH IN (B)(4) FOR FURTHER INVESTIGATION. THE RETURNED MANOMETER WAS FITTED INTO A KNOWN GOOD VALVE SYSTEM AND PERFORMANCE TESTED BASED ON THE NEOPUFF TECHNICAL MANUAL. OUR INVESTIGATION IS ACCORDINGLY BASED ON THE SERVICE INFORMATION AND PHOTOGRAPHS PROVIDED BY FPH SERVICE ENGINEER, AND THE RESULTS OF THE INVESTIGATION AT FPH NEW ZEALAND. RESULTS: THE FAULT REPORTED BY THE MEDICAL CENTER REGARDING THE NEOPUFF UNITS DELIVERING INACCURATE PRESSURES WERE NOT REPLICATED DURING SERVICING. HOWEVER, THE UNIT WITH SN (B)(4) WAS FOUND TO HAVE CRACKED ENCLOSURE, AND THE OTHER UNIT WITH SN (B)(4) HAD DAMAGED UPPER END CAP ALSO ON THE ENCLOSURE. NO FAULT WAS FOUND WITH THE RETURNED MANOMETER. IT FUNCTIONED NORMALLY DURING PERFORMANCE TEST. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR BOTH LOT NUMBERS. CONCLUSION: THE NEOPUFF IS A PORTABLE, REUSABLE DEVICE USED TO ASSIST IN THE DELIVERY OF RESPIRATORY BREATHS TO INFANT 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 PHYSICAL DAMAGES OBSERVED WERE MOST LIKELY DUE TO IMPACT TO THE SUBJECT NEOPUFF UNITS. THE NEOPUFF TECHNICAL MANUAL STATES THE FOLLOWING: "DROPPING THE NEOPUFF 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." EACH NEOPUFF UNIT IS ASSEMBLED AND 100% TESTED IN THE PRODUCTION LINE TO VERIFY THAT EACH UNIT CONFORMS TO CRITICAL PRODUCT SPECIFICATIONS. ANY UNIT THAT FAILS IS REJECTED. THIS SUGGESTS THAT THE SUBJECT NEOPUFF UNITS WERE DAMAGED AFTER RELEASED FOR DISTRIBUTION. BOTH NEOPUFF UNITS WERE REPAIRED AND RETURNED TO THE MEDICAL CENTER AFTER PASSING THE PERFORMANCE TESTS SPECIFIED IN THE NEOPUFF TECHNICAL MANUAL.

    Description of Event or Problem · 1

    A MEDICAL CENTER IN (B)(6) REPORTED THAT TWO RD900AEU NEOPUFF INFANT RESUSCITATORS NEEDED CALIBRATION AS THE UNITS WERE DELIVERING INACCURATE PRESSURE. THIS WAS OBSERVED BEFORE THE UNITS WERE USED ON PATIENTS. THE MEDICAL CENTER ALSO REQUESTED TO SERVICE THE SUBJECT NEOPUFF UNITS.

    Description of Event or Problem · 1

    A MEDICAL CENTER IN (B)(6) REPORTED THAT TWO RD900AEU NEOPUFF INFANT RESUSCITATORS NEEDED CALIBRATION AS THE UNITS WERE DELIVERING INACCURATE PRESSURES. THIS WAS OBSERVED BEFORE THE UNITS WERE USED ON PATIENTS. THE MEDICAL CENTER ALSO REQUESTED TO SERVICE THE SUBJECT NEOPUFF UNITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665925 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LIMITED RD900AEU

    Patients

    Seq Age Sex Outcome Treatment
    1