BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 3058852 · Received April 15, 2013

    Report

    Report Number
    9611451-2013-00272
    Event Type
    Malfunction
    Date Received
    April 15, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 21, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RD900AFU NEOPUFF INFANT RESUSCITATOR WAS RETURNED TO OUR FISHER & PAYKEL HEALTHCARE (FPH) SERVICE CENTRE IN (B)(4), WHERE IT WAS VISUALLY INSPECTED AND PERFORMANCE TESTED BY A TRAINED FPH SERVICE ENGINEER. OUR ANALYSIS IS ACCORDINGLY BASED ON THE EVENT DESCRIPTION AND SERVICE REPORT PROVIDED BY THE FPH SERVICE ENGINEER. RESULTS: THE HEALTHCARE FACILITY REPORTED THAT THE PRESSURE ON THE SUBJECT NEOPUFF UNIT WAS NOT INCREASING. UPON INSPECTION, IT WAS OBSERVED THAT THE VALVE WAS BROKEN, CAUSING THE REPORTED FAULT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 030804. 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. IT IS MOST LIKELY THAT THE DAMAGE OBSERVED TO THE NEOPUFF VALVE WAS DUE TO IMPACT. 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 UNIT WILL BE SENT BACK TO THE HEALTHCARE FACILITY ONCE THE VALVE SYSTEM HAS BEEN REPLACED, AND PASSED THE PERFORMANCE TESTS SPECIFIED IN OUR NEOPUFF TECHNICAL MANUAL.

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE CURRENTLY IN THE PROCESS OF OBTAINING THE COMPLAINT RD900AFU NEOPUFF INFANT RESUSCITATOR FROM THE HEALTHCARE FACILITY. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE RECEIVED THE COMPLAINT DEVICE AND COMPLETED OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE PRESSURE ON AN RD900AFU NEOPUFF INFANT RESUSCITATOR WAS NOT INCREASING. THE CIRCUITS CONNECTED TO THE NEOPUFF WERE CHANGED BUT THE PROBLEM WITH THE PRESSURE WAS NOT RESOLVED. THIS WAS OBSERVED DURING PERFORMANCE CHECK OF THE NEOPUFF AT THE HEALTHCARE FACILITY.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE PRESSURE ON AN RD900AFU NEOPUFF INFANT RESUSCITATOR WAS NOT INCREASING. THE CIRCUITS CONNECTED TO THE NEOPUFF WERE CHANGED BUT THE PROBLEM WITH THE PRESSURE WAS NOT RESOLVED. THIS WAS OBSERVED DURING PERFORMANCE CHECK OF THE NEOPUFF AT THE HEALTHCARE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161640 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LIMITED RD900AFU

    Patients

    Seq Age Sex Outcome Treatment
    1