BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 5209747 · Received November 8, 2015

    Report

    Report Number
    9611451-2015-00467
    Event Type
    Malfunction
    Date Received
    November 8, 2015
    Report Date
    October 13, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE FASCIA AND VALVE ASSEMBLY OF THE COMPLAINT RD900AEU NEOPUFF INFANT RESUSCITATOR WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) AND WAS VISUALLY INSPECTED. OUR ANALYSIS IS ACCORDINGLY BASED ON THE RESULTS OF OUR INVESTIGATION AND PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS. RESULTS: VISUAL INSPECTION REVEALED THAT THE GAS OUTLET PORT OF THE RETURNED NEOPUFF UNIT WAS BROKEN, CONFIRMING THE REPORTED FAULT. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT NUMBER 090518. 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 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 FASCIA AND VALVE ASSEMBLY OF THE SUBJECT NEOPUFF UNIT WAS DAMAGED AFTER IT WAS RELEASED FOR DISTRIBUTION. THE FASCIA AND VALVE ASSEMLY WAS REPLACED AND THE NEOPUFF UNIT WAS RETURNED TO THE HEALTHCARE FACILITY AFTER PASSING THE PERFORMANCE CHECKS SPECIFIED IN THE NEOPUFF PRODUCT TECHNICAL MANUAL.

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE CURRENTLY IN THE PROCESS OF OBTAINING FURTHER INFORMATION FROM THE HEALTHCARE FACILITY IN ORDER TO ASSIST US WITH THE ANALYSIS AND IDENTIFICATION OF A POSSIBLE ROOT CAUSE OF THE REPORTED EVENT. WE WILL PROVIDE A FOLLOW UP REPORT ONCE WE HAVE COMPLETED OUR ANALYSIS.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE GAS OUTLET PORT OF AN RD900AEU NEOPUFF INFANT RESUSCITATOR HAD BROKEN OFF. THIS WAS OBSERVED BEFORE USE ON A PATIENT.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE GAS OUTLET PORT OF AN RD900AEU NEOPUFF INFANT RESUSCITATOR HAD BROKEN OFF. THIS WAS OBSERVED BEFORE USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739967 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LIMITED RD900AEU

    Patients

    Seq Age Sex Outcome Treatment
    1