BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 1941617 · Received December 29, 2010

    Report

    Report Number
    9611451-2010-00805
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Report Date
    December 7, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT NEOPUFF DEVICE HAS NOT YET BEEN RECEIVED FOR EVALUATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT OF THE DEVICE AND COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RD900AEU NEOPUFF INFANT RESUSCITATOR WAS RETURNED TO FPH SERVICE CENTER IN (B)(4) FOR INSPECTION. IT WAS VISUALLY INSPECTED FOR THE REPORTED DAMAGE. RESULTS: VISUAL INSPECTION REVEALED THAT THE PRESSURE CONTROL VALVE OF THE NEOPUFF DEVICE WAS STUCK, CONFIRMING THE REPORTED FAULT. CONCLUSION: THE NEOPUFF IS A PORTABLE REUSABLE DEVICE WHICH CAN BE SUSCEPTIBLE TO IMPACT DAMAGE. THE VALVE CAN BECOME ERRATIC IF SUBJECTED TO A LARGE ENOUGH IMPACT, FOR INSTANCE IF ACCIDENTALLY DROPPED. THE NEOPUFF'S USER INSTRUCTIONS ADVISE THE USER TO CARRY OUT A PERFORMANCE CHECK AND RECALIBRATION OF THE DEVICE SHOULD IT RECEIVE AN IMPACT. NO PATIENT CONSEQUENCE WAS REPORTED AS A RESULT OF THIS INCIDENT.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(4) REPORTED THAT THE INSPIRATORY PRESSURE VALVE ON AN RD900AEU NEOPUFF INFANT RESUSCITATOR WAS STUCK. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED THAT THE INSPIRATORY PRESSURE VALVE ON AN RD900 NEOPUFF INFANT RESUSCITATOR IS STUCK. 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 RD900AEU 081219

    Patients

    Seq Age Sex Outcome Treatment
    1