BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 3117364 · Received May 17, 2013

    Report

    Report Number
    9611451-2013-00381
    Event Type
    Malfunction
    Date Received
    May 17, 2013
    Report Date
    April 17, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RETURNED DEVICES: DEVICE 1: RD900 NEOPUFF INFANT RESUSCITATOR, LOT NUMBER: 060729. DEVICE 2: RD900 NEOPUFF INFANT RESUSCITATOR, LOT NUMBER: 030709. METHOD: THE COMPLAINT NEOPUFF INFANT RESUSCITATORS WERE RETURNED TO OUR FISHER & PAYKEL HEALTHCARE (FPH) SERVICE CENTRE IN (B)(4) WHERE THEY WERE VISUALLY EXAMINED AND PERFORMANCE TESTED TO OUR SPECIFICATIONS BY A TRAINED FPH SERVICE ENGINEER. OUR INVESTIGATION IS BASED ON THE PHOTOGRAPHS, SERVICE REPORTS PROVIDED BY OUR SERVICE CENTRE IN (B)(4) AND OUR KNOWLEDGE OF OUR PRODUCTS. RESULTS: DEVICE 1: VISUAL EXAMINATION REVEALED THAT THE GAS INLET PORT AND THE LOWER END CAP WERE CRACKED. THE PERFORMANCE TEST REVEALED THAT THE MANOMETER WAS OUT OF SPECIFICATION. FURTHER INSPECTION REVEALED THAT BOTH PLUG SETS WERE MISSING. DEVICE 2: VISUAL EXAMINATION REVEALED THAT THE GAS OUTLET PORT WAS BROKEN. DAMAGE TO THE UPPER AND LOWER END CAPS WAS ALSO NOTED AND BOTH PLUG SETS WERE MISSING. INSPECTION OF THE MANOMETER REVEALED THAT IT WAS OUT OF SPECIFICATION. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBERS 060729 AND 030709. CONCLUSION: THE NEOPUFF IS A PORTABLE, REUSABLE DEVICE USED TO ASSIST IN THE DELIVERY OF RESPIRATORY BREATHS TO AN 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. DEVICE 1 HAS BEEN FUNCTIONING CORRECTLY FOR OVER SIX YEARS WHILE DEVICE 2 HAS BEEN FUNCTIONING CORRECTLY FOR NEARLY TEN YEARS. IT IS MOST LIKELY THAT THE DAMAGE OBSERVED ON BOTH OF THE RETURNED RD900 NEOPUFF INFANT RESUSCITATORS WAS DUE 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."

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT TWO RD900 NEOPUFF RESUSCITATORS WERE DAMAGED. THEY REPORTED THAT THE GAS INLET PORT WAS DAMAGED ON ONE RD900 NEOPFUFF INFANT RESUSCITATOR AND THE OTHER NEOPUFF DEVICE WAS OUT OF CALIBRATION. A SERVICE OF THE NEOPUFF DEVICES WAS ALSO REQUESTED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219074 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LTD RD900 060729

    Patients

    Seq Age Sex Outcome Treatment
    1