BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 3493368 · Received November 27, 2013

    Report

    Report Number
    9611451-2013-00955
    Event Type
    Malfunction
    Date Received
    November 27, 2013
    Report Date
    October 31, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RD900 NEOPUFF INFANT RESUSCITATOR WAS RETURNED TO OUR FISHER & PAYKEL HEALTHCARE (FPH) SERVICE CENTER IN (B)(4), WHERE IT WAS INSPECTED BY A TRAINED FPH TECHNICIAN. RESULTS: VISUAL INSPECTION OF THE NEOPUFF REVEALED THAT THE GAS INLET PORT WAS BROKEN. THE CASING WAS ALSO CRACKED AND PRESSURE TESTING REVEALED THAT THE MANOMETER WAS FAULTY. A LOT CHECK REVEALED TWO OTHER COMPLAINTS OF THIS TYPE FOR LOT NUMBER 070208. CONCLUSION: 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. IT IS MOST LIKELY THAT THE PHYSICAL DAMAGE TO THE GAS INLET PORT, CASING AND MANOMETER WAS CAUSED BY SOME SORT OF 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."

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620402 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LTD RD900 070208

    Patients

    Seq Age Sex Outcome Treatment
    1