BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 3228291 · Received July 15, 2013

    Report

    Report Number
    9611451-2013-00531
    Event Type
    Malfunction
    Date Received
    July 15, 2013
    Report Date
    June 19, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT NEOPUFF WAS RETURNED TO OUR REGIONAL OFFICE IN (B)(4). THE NEOPUFF WAS INSPECTED AND REPAIRED BY A TRAINED FISHER & PAYKEL HEALTHCARE SERVICE ENGINEER. OUR INVESTIGATION IS BASED ON OUR EVALUATION OF THE RETURNED FAULTY COMPONENTS AND THE SERVICE REPORT PROVIDED BY OUR (B)(4) OFFICE. RESULTS: VISUAL INSPECTION OF THE RETURNED COMPLAINT FASCIA AND VALVE SYSTEM REVEALED PHYSICAL DAMAGE TO THE GAS OUTLET PORT THAT APPEARED TO BE THE RESULT OF AN IMPACT TO THE DEVICE. A LOT CHECK REVEALED ONE OTHER COMPLAINT FOR A BROKEN OUTLET PORT FOR LOT 101129. 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. 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". THE FASCIA AND VALVE SYSTEM WAS REPLACED AND THE NEOPUFF WAS RETURNED TO THE CUSTOMER AFTER IT PASSED ALL PERFORMANCE AND SAFETY TESTS AS PER THE NEOPUFF TECHNICAL MANUAL.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE GAS OUTLET PORT OF A NEOPUFF INFANT RESUSCITATOR WAS BROKEN AND REQUESTED A REPAIR. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325701 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LTD RD900 101129

    Patients

    Seq Age Sex Outcome Treatment
    1