BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 2651738 · Received July 12, 2012

    Report

    Report Number
    9611451-2012-00454
    Event Type
    Malfunction
    Date Received
    July 12, 2012
    Report Date
    June 15, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    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 RD900AFU NEOPUFF INFANT RESUSCITATOR WAS RETURNED TO FISHER & PAYKEL HEALTHCARE SERVICE CENTRE IN (B)(4) FOR EVALUATION. RESULTS: INSPECTION REVEALED THAT THE GAS INLET PORT WAS BROKEN AND THE MANOMETER WAS FAULTY. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 050826. 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 DAMAGES TO THE NEOPUFF GAS INLET PORT AND MANOMETER 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."

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT RD900AFU NEOPUFF INFANT RESUSCITATOR IS EN ROUTE TO FISHER & HEALTHCARE (FPH) SERVICE CENTRE IN (B)(4) FOR REPAIR. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE COMPLETED THE REPAIR.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE GAS INLET PORT OF AN RD900AFU NEOPUFF INFANT RESUSCITATOR HAD BROKEN OFF. THIS WAS OBSERVED AFTER PATIENT USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE GAS INLET PORT OF AN RD900AFU NEOPUFF INFANT RESUSCITATOR HAD BROKEN OFF. THIS WAS OBSERVED AFTER PATIENT USE. 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 RD900AFU

    Patients

    Seq Age Sex Outcome Treatment
    1