BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 4876518 · Received June 29, 2015

    Report

    Report Number
    9611451-2015-00297
    Event Type
    Malfunction
    Date Received
    June 29, 2015
    Report Date
    June 15, 2015
    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). METHOD: THE COMPLAINT (B)(4) NEOPUFF INFANT RESUSCITATOR WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) SERVICE CENTER IN (B)(4), WHERE IT WAS INSPECTED AND REPAIRED BY A TRAINED FPH SERVICE MANAGER. OUR INVESTIGATION IS ACCORDINGLY BASED ON THE SERVICE REPORT PROVIDED BY FPH SERVICE CENTER. RESULTS: INSPECTION CONDUCTED AT FPH SERVICE CENTER IN (B)(4) REVEALED THAT THE TUBE THAT WAS CONNECTED TO THE MANOMETER INLET PORT WAS LOOSE, CAUSING THE REPORTED FAULT ON THE MANOMETER NEEDLE. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT NUMBER 140527. CONCLUSION: THE REPORTED FAULT WAS DUE TO THE LOOSE CONNECTION OF THE PVC TUBE TO THE MANOMETER INLET PORT. IT IS LIKELY THAT THE TUBE WAS NOT INSERTED PROPERLY DURING ASSEMBLY AND BECAME LOOSE DURING SHIPPING OR TRANSPORTATION. NO PATIENT CONSEQUENCE WAS REPORTED AS A RESULT OF THIS INCIDENT. ALL NEOPUFF UNITS ARE VISUALLY INSPECTED AND PERFORMANCE TESTED BEFORE LEAVING THE PRODUCTION LINE AND THOSE THAT FAIL ARE REJECTED. THE NEOPUFF TECHNICAL MANUAL STATES THE FOLLOWING: "DROPPING THE NEOPUFF 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 FPH SERVICE MANAGER RECONNECTED THE LOOSE TUBE TO THE MANOMETER INLET PORT AND RETURNED THE SUBJECT NEOPUFF UNIT TO THE DISTRIBUTOR AFTER PASSING THE PERFORMANCE CHECK SPECIFIED IN THE NEOPUFF TECHNICAL MANUAL.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(4) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THE MANOMETER NEEDLE OF AN (B)(4) NEOPUFF INFANT RESUSCITATOR WAS NOT MOVING. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419548 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LIMITED RD900AEU

    Patients

    Seq Age Sex Outcome Treatment
    1