BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 2784533 · Received October 11, 2012

    Report

    Report Number
    9611451-2012-00726
    Event Type
    Malfunction
    Date Received
    October 11, 2012
    Date of Event
    August 30, 2012
    Report Date
    September 13, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RD900 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. THE FAULTY MANOMETER WAS THEN RETURNED TO FPH IN (B)(4) FOR FURTHER PERFORMANCE TESTING. RESULTS: VISUAL INSPECTION DID NOT REVEAL ANY PHYSICAL DAMAGE TO THE EXTERIOR OF THE CASE. THE PERFORMANCE TEST REVEALED THAT THE MANOMETER WAS WITHIN SPECIFICATION, HOWEVER THE NEEDLE MOVEMENT WAS NOT SMOOTH. A LOT CHECK DID NOT REVEAL ANY OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 111221. 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. IN ADDITION THE NEOPUFF USER INSTRUCTIONS STATE THAT THE USER SHOULD "CHECK MANOMETER READS ZERO WITH NO GAS FLOW" AND CHECK THE PRESSURE SETTINGS "PRIOR TO EVERY USE OF THE NEOPUFF". THE INVESTIGATION OF SIMILAR COMPLAINTS HAS REVEALED THAT THIS TYPE OF DAMAGE WAS MOST LIKELY CAUSED BY SOME FORM OF IMPACT TO THE NEOPUFF DEVICE. THE COMPLAINT NEOPUFF DEVICE WAS SERVICED AND THE FAULTY MANOMETER WAS REPLACED. THE NEOPUFF DEVICE WAS THEN RETURNED TO THE CUSTOMER FACILITY.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE MANOMETER ON AN RD900 NEOPFUFF INFANT RESUSCITATOR WAS STUCK AND NOT FUNCTIONING. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE MANOMETER ON AN RD900 NEOPFUFF INFANT RESUSCITATOR WAS STUCK AND NOT FUNCTIONING. 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 LTD RD900AEU 111221

    Patients

    Seq Age Sex Outcome Treatment
    1