BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 3109988 · Received May 13, 2013

    Report

    Report Number
    9611451-2013-00378
    Event Type
    Malfunction
    Date Received
    May 13, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 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). METHOD: THE COMPLAINT RD900 NEOPUFF DEVICE WAS INSPECTED AND REPAIRED BY TRAINED PERSONNEL AT THE FISHER & PAYKEL HEALTHCARE REGIONAL OFFICE IN (B)(4). RESULTS: THE MAXIMUM PRESSURE OF THE COMPLAINT RD900 DEVICE COULD NOT BE ADJUSTED. THE VALVE ASSEMBLY OF THE COMPLAINT RD900 DEVICE WAS CONFIRMED TO BE BROKEN. A LOT CHECK REVEALED NO OTHER COMPLAINT OF THIS TYPE FOR LOT NUMBER 080314. 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 DAMAGE TO 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)(4) REPORTED THAT THE MAXIMUM PRESSURE OF AN RD900 NEOPUFF INFANT RESUSCITATOR COULD NOT BE ADJUSTED AS THE VALVE WAS BROKEN AND NEEDS TO BE REPLACED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210336 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LTD RD900

    Patients

    Seq Age Sex Outcome Treatment
    1