BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 1735952 · Received June 21, 2010

    Report

    Report Number
    9611451-2010-00387
    Event Type
    Other
    Date Received
    June 21, 2010
    Report Date
    June 10, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD.
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - METHOD: THE COMPLAINT DEVICE WAS RETURNED TO FISHER & PAYKEL HEALTHCARE'S REGIONAL OFFICE AND SERVICE CENTER IN THE (B)(4) FOR INVESTIGATION. THE COMPLAINT DEVICE WAS VISUALLY INSPECTED FOR DAMAGE. FURTHER INFORMATION WAS REQUESTED FROM THE CUSTOMER. THE INFORMATION PROVIDED WAS ALSO USED IN THE COMPLAINT INVESTIGATION. RESULTS: THE INLET AND OUTLET PORTS ON THE FRONT OF THE NEOPUFF WERE DAMAGED, CONFIRMING THE REPORT FROM THE CUSTOMER. WHEN FURTHER INFORMATION WAS REQUESTED FROM THE HOSPITAL REGARDING THE TIMING OF USE WHEN THE PORTS BROKE, THE COMPLAINANT ADVISED THAT THE NEOPUFF HAD BEEN NEW. IT WAS REPORTED THAT THE DEVICE WAS HIT BY A TROLLEY AFTER BEING REMOVED FROM THE PACKAGING. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 100312. CONCLUSION: THE HOSPITAL ADVISED THAT THE NEOPUFF HAD BEEN HIT BY A TROLLEY AFTER IT WAS REMOVED FROM THE PACKAGING. THE IMPACT DAMAGE FROM THE TROLLEY WOULD HAVE CAUSED THE REPORTED DAMAGE TO THE NEOPUFF. 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."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN RD900 NEOPUFF INFANT RESUSCITATOR HAD A BROKEN GAS OUTLET AND CRACKED GAS INLET. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEOPUFF INFANT RESUSCITATOR BTL FISHER & PAYKEL HEALTHCARE LTD. RD900AEU 100312

    Patients

    Seq Age Sex Outcome Treatment
    1