BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 5589827 · Received April 20, 2016

    Report

    Report Number
    9611451-2016-00162
    Event Type
    Malfunction
    Date Received
    April 20, 2016
    Report Date
    March 21, 2016
    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 MANOMETER OF THE COMPLAINT RD900AFU NEOPUFF INFANT RESUSCITATOR WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR INSPECTION. IT WAS VISUALLY INSPECTED FOR PHYSICAL DAMAGE. THE MANOMETER WAS PERFORMANCE TESTED BY FITTING INTO A KNOWN GOOD VALVE SYSTEM AND TESTED BASED ON THE NEOPUFF TECHNICAL MANUAL. RESULTS: NO PHYSICAL DAMAGE WAS OBSERVED TO THE RETURNED MANOMETER. THERE WAS ALSO NO BLOCKAGE OBSERVED ON THE MANOMETER INLET PORT. HOWEVER, THE MANOMETER FAILED THE PERFORMANCE TEST SPECIFIED IN THE NEOPUFF TECHNICAL MANUAL. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 140702. 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. ALL NEOPUFF UNITS, INCLUDING THE MANOMETERS, ARE VISUALLY INSPECTED FOR ANY DEFECTS AND PERFORMANCE TESTED FOR FUNCTIONALITY PRIOR TO LEAVING THE PRODUCTION LINE. THOSE THAT FAIL ARE REJECTED. THE DAMAGE TO THE MANOMETER IS MOST LIKELY CAUSED BY SIGNIFICANT IMPACT. THE NEOPUFF TECHNICAL MANUAL WARNS AGAINST DROPPING THE NEOPUFF OR SUBJECTING IT TO IMPACT DAMAGE WHICH MAY CAUSE THE UNIT TO OPERATE INCORRECTLY. IF THE NEOPUFF IS SUSPECTED TO HAVE BEEN DAMAGED, THE MANOMETER AND VALVE SYSTEM SHOULD BE PERFORMANCE TESTED. 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". IN ADDITION THE NEOPUFF USER INSTRUCTIONS STATE THAT THE USER SHOULD "CHECK MANOMETER READS ZERO WITH NO GAS FLOW" AND CHECK THE PRESSURE SETTINGS "PRIOR TO EVERY USE OF THE NEOPUFF". THE DEFECTIVE MANOMETER WAS REPLACED AND THE SUBJECT NEOPUFF UNIT WAS RETURNED TO THE HOSPITAL SERVICE AFTER PASSING THE PERFORMANCE CHECKS SPECIFIED IN THE NEOPUFF TECHNICAL MANUAL.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE WAS RECENTLY RETURNED TO OUR SERVICE CENTRE IN (B)(4) FOR EVALUATION. OUR INVESTIGATION IS CURRENTLY IN PROGRESS AND WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE MANOMETER ON AN RD900 NEOPUFF INFANT RESUSCITATOR WAS BLOCKED. THEY FURTHER REQUESTED A REPAIR OF THE DEVICE. THIS WAS FOUND PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE MANOMETER ON AN RD900 NEOPUFF INFANT RESUSCITATOR WAS BLOCKED. THEY FURTHER REQUESTED A REPAIR OF THE DEVICE. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246036 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LTD RD900 140702

    Patients

    Seq Age Sex Outcome Treatment
    1