BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 3026404 · Received March 28, 2013

    Report

    Report Number
    9611451-2013-00221
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Report Date
    March 1, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT RD900 NEOPUFF DEVICE WAS RECENTLY REPAIRED BY A TRAINED PERSONNEL AT FISHER & PAYKEL HEALTHCARE REGIONAL OFFICE IN (B)(4). THE FAULTY COMPONENTS ARE CURRENTLY IN TRANSIT TO FPH (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT OF THE COMPONENTS OF THE COMPLAINT DEVICE AND COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RD900 NEOPUFF DEVICE WAS REPAIRED BY TRAINED PERSONNEL AT THE FISHER & PAYKEL HEALTHCARE REGIONAL OFFICE IN (B)(4). THE VALVE ASSEMBLY OF THE COMPLAINT NEOPUFF DEVICE WAS RETURNED TO FPH (B)(4) FOR EVALUATION. RESULTS: VISUAL INSPECTION REVEALED THAT THE OUTLET PORT OF THE RETURNED VALVE ASSEMBLY WAS BROKEN. A LOT CHECK REVEALED NO OTHER COMPLAINT OF THIS TYPE FOR LOT NUMBER 091102. 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. THE BROKEN OUTLET PORT OF THE VALVE ASSEMBLY IS MOST LIKELY TO HAVE BEEN CAUSED BY EXCESSIVE IMPACT DAMAGE. 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." THE COMPLAINT NEOPUFF DEVICE WAS FITTED WITH A NEW FRONT PANEL AND VALVE ASSEMBLY, GIVEN A PERFORMANCE CHECK, AND RETURNED TO THE CUSTOMER FULLY FUNCTIONING AS PER SPECIFICATIONS.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED THAT THE GAS OUTLET PORT OF AN RD900 INFANT RESUSCITATOR WAS BROKEN. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED THAT THE GAS OUTLET PORT OF AN RD900 INFANT RESUSCITATOR WAS BROKEN. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127975 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LTD RD900

    Patients

    Seq Age Sex Outcome Treatment
    1