BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 3062114 · Received April 16, 2013

    Report

    Report Number
    9611451-2013-00279
    Event Type
    Malfunction
    Date Received
    April 16, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    V. METHOD: THE COMPLAINT RD900AEU NEOPUFF INFANT RESUSCITATOR WAS RETURNED TO OUR FISHER & PAYKEL HEALTHCARE (FPH) SERVICE CENTRE IN (B)(4), WHERE INITIAL VISUAL INSPECTION AND PERFORMANCE TEST WERE CONDUCTED BY A TRAINED FPH SERVICE ENGINEER. THE FAULTY FASCIA, VALVE SYSTEM, AND UPPER END CAP WERE SUBSEQUENTLY RETURNED TO FPH IN (B)(4) AND FURTHER INSPECTION WAS CONDUCTED. RESULTS: THE SUBJECT NEOPUFF UNIT FAILED THE VISUAL INSPECTION AND PERFORMANCE TEST CONDUCTED AT FPH SERVICE CENTRE IN (B)(4). IT WAS OBSERVED THAT THE FASCIA, VALVE SYSTEM, AND UPPER END CAP WERE CRACKED. THIS WAS CONFIRMED WHEN THE SUBJECT COMPONENTS WERE RETURNED AND INSPECTED AT FPH (B)(4). THE COMPLAINT VALVE SYSTEM PASSED THE PERFORMANCE TESTS SPECIFIED IN THE NEOPUFF PRODUCT TECHNICAL MANUAL WHEN A TEST MANOMETER WAS FITTED TO IT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 061115. 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 DAMAGES OBSERVED TO THE NEOPUFF WAS DUE TO SIGNIFICANT IMPACT. THE NEOPUFF PRODUCT 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 WAS RETURNED TO THE HOSPITAL AFTER IT WAS REPAIRED AND PASSED THE PERFORMANCE TESTS SPECIFIED IN THE PRODUCT TECHNICAL MANUAL.

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE CURRENTLY IN THE PROCESS OF OBTAINING THE COMPLAINT RD900AEU NEOPUFF INFANT RESUSCITATOR FROM THE HOSPITAL. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE RECEIVED THE COMPLAINT DEVICE AND COMPLETED OUR INSPECTION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE POSITIVE END EXPIRATORY PRESSURE (PEEP) OF AN RD900AEU NEOPUFF INFANT RESUSCITATOR WAS STUCK AT 5CMH2O. THE HOSPITAL STAFF REPORTED THAT IT WAS NOT USED FOR A LONG TIME AND REQUESTED IT TO BE REPAIRED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE POSITIVE END EXPIRATORY PRESSURE (PEEP) OF AN RD900AEU NEOPUFF INFANT RESUSCITATOR WAS STUCK AT 5CMH2O. THE HOSPITAL STAFF REPORTED THAT IT WAS NOT USED FOR A LONG TIME AND REQUESTED IT TO BE REPAIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163943 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LIMITED RD900AEU

    Patients

    Seq Age Sex Outcome Treatment
    1