BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 2769658 · Received October 2, 2012

    Report

    Report Number
    9611451-2012-00703
    Event Type
    Malfunction
    Date Received
    October 2, 2012
    Date of Event
    September 13, 2012
    Report Date
    September 20, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RD900AEU NEOPUFF INFANT RESUSCITATOR WAS RECEIVED FOR SERVICE AT OUR FISHER & PAYKEL HEALTHCARE (FPH) SERVICE CENTRE IN (B)(4) WHERE IT WAS INSPECTED BY A TRAINED FPH TECHNICIAN. THE RETURNED NEOPUFF UNIT WAS VISUALLY INSPECTED FOR DAMAGE AND PERFORMANCE TESTED IN ACCORDANCE WITH THE NEOPUFF TECHNICAL MANUAL. OUR ANALYSIS IS BASED ON THE SERVICE FINDINGS PROVIDED BY OUR SERVICE CENTRE. RESULTS: VISUAL INSPECTION REVEALED THAT THE PLUG SET WAS MISSING. NO OTHER PHYSICAL DAMAGE WAS NOTED TO THE RETURNED NEOPUFF UNIT. THE REPORTED FAULT WITH THE MANOMETER WAS NOT REPLICATED DURING PERFORMANCE CHECK. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 061012. CONCLUSION: NO FAULT WAS FOUND WITH THE MANOMETER OF THE RETURNED NEOPUFF UNIT. IF FUNCTIONED AS INTENDED DURING PERFORMANCE CHECK. 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/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." FOLLOWING INSPECTION OF THE MANOMETER AND REPLACEMENT OF THE PLUG SET, THE NEOPUFF UNIT WAS RETURNED TO THE HOSPITAL.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(4) REPORTED THAT AN RD900 NEOPUFF INFANT RESUSCITATOR WOULD NOT CALIBRATE OR VERIFY THE MANOMETER PRESSURES. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1