BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 3408751 · Received October 14, 2013

    Report

    Report Number
    9611451-2013-00807
    Event Type
    Malfunction
    Date Received
    October 14, 2013
    Date of Event
    September 16, 2013
    Report Date
    September 19, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE CURRENTLY IN THE PROCESS OF OBTAINING THE COMPLAINT RD900AWU NEOPUFF INFANT RESUSCITATOR FROM THE HEALTHCARE FACILITY. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE RECEIVED THE COMPLAINT DEVICE AND COMPLETED OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RD900AWU NEOPUFF INFANT RESUSCITATOR WAS RETURNED TO FPH SERVICE CENTRE IN FRANCE, WHERE IT WAS INSPECTED BY A TRAINED FPH TECHNICIAN. RESULTS: INSPECTION OF THE RETURNED NEOPUFF UNIT REVEALED THAT THE GAS OUTLET PORT HAD BROKEN OFF. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 120314. 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. 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." ALL NEOPUFF UNITS ARE VISUALLY INSPECTED AND PERFORMANCE TESTED BEFORE LEAVING THE PRODUCTION LINE AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THAT THE DAMAGE OCCURRED AFTER THE SUBJECT NEOPUFF UNIT WAS RELEASED FOR DISTRIBUTION. THE DAMAGED NEOPUFF UNIT IS STILL WITH THE SERVICE CENTRE. THE FPH TECHNICIAN IS STILL WAITING FOR THE HEALTHCARE FACILITY'S REPAIR APPROVAL.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THE GAS OUTLET PORT OF AN RD900AWU NEOPUFF INFANT RESUSCITATOR BROKE EASILY WHEN CONNECTING THE 900RD010 ADJUSTABLE T-PIECE AND RESUSCITATION CIRCUIT. THIS WAS OBSERVED BEFORE USE ON A PATIENT.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THE GAS OUTLET PORT OF AN RD900AWU NEOPUFF INFANT RESUSCITATOR BROKE EASILY WHEN CONNECTING THE 900RD010 ADJUSTABLE T-PIECE AND RESUSCITATION CIRCUIT. THIS WAS OBSERVED BEFORE USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525704 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LIMITED RD900AWU

    Patients

    Seq Age Sex Outcome Treatment
    1