BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 2344644 · Received November 21, 2011

    Report

    Report Number
    9611451-2011-00723
    Event Type
    Malfunction
    Date Received
    November 21, 2011
    Date of Event
    August 9, 2011
    Report Date
    October 27, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SERIAL # & DEVICE MANUFACTURE DATE: (B)(4) - 01/21/2011, (B)(4) - 01/18/2011, (B)(4) - 11/05/2010. THE COMPLAINT (B)(4) NEOPUFF INFANT RESUSCITATORS ARE EN ROUTE TO FISHER & PAYKEL HEALTHCARE SERVICE CENTRE IN (B)(4) FOR SERVICING. WE WILL PROVIDE A FOLLOW UP REPORT ONCE OUR SERVICE CENTRE HAS RECEIVED THE COMPLAINT DEVICES AND COMPLETED THE INSPECTION.

    Additional Manufacturer Narrative · 1

    (B)(4). SERIAL # AND LOT # AND DEVICE MANUFACTURE DATE: SERIAL: (B)(4), LOT: 110121 - 01/21/2011; SERIAL: (B)(4), LOT: 110118, - 01/18/2011; SERIAL: (B)(4), LOT: 101105, - 11/05/2010. METHOD: THE 3 COMPLAINT DEVICES (LOTS 110121, 110118, 101105) HAVE NOT BEEN RETURNED TO THE MANUFACTURER. THEY HAVE BEEN VISUALLY INSPECTED BY A TRAINED FISHER & PAYKEL HEALTHCARE SERVICE ENGINEER AT OUR REGIONAL OFFICE IN THE USA. RESULTS: THE VISUAL INSPECTION OF THE COMPLAINT DEVICE WITH LOT 110121 REVEALED THE GAS OUTLET PORT TO BE BROKEN, WHICH APPEARED TO BE AS A RESULT OF PHYSICAL DAMAGE. THE VISUAL INSPECTION OF THE OTHER TWO COMPLAINT DEVICES WITH LOT 110118 AND 101105 REVEALED THE GAS OUTLET PORTS TO BE BROKEN, WHICH APPEARED TO BE AS A RESULT OF IMPACT DAMAGE. THE VISUAL INSPECTION OF COMPLAINT DEVICE WITH LOT 101105 ALSO IDENTIFIED THE LOWER END CAP AND PLUGS TO BE MISSING. A LOT CHECK REVEALED ONE OTHER SIMILAR COMPLAINT FOR LOT 110121. A LOT CHECK REVEALED NO OTHER SIMILAR COMPLAINTS FOR LOTS 110118 AND 101105. 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. IT IS MOST LIKELY THAT THE DAMAGE TO THE NEOPUFF GAS OUTLET PORTS WERE 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 THREE NEOPUFF UNITS WERE RETURNED TO THE HEALTHCARE FACILITY AFTER THE FASCIA AND VALVE ASSEMBLY WERE REPLACED AND PERFORMANCE TESTED BY FPH SERVICE CENTRE IN THE USA. THE LOWER END CAP AND PLUGS WERE ALSO REPLACED ON THE NEOPUFF WITH LOT 101105.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THREE RD900AEU NEOPUFF INFANT RESUSCITATORS HAD DAMAGED GAS OUTLET PORTS. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THREE (B)(4) NEOPUFF INFANT RESUSCITATORS HAD DAMAGED GAS OUTLET PORTS. 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