BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 1004709 · Received March 3, 2008

    Report

    Report Number
    9611451-2008-00066
    Event Type
    Malfunction
    Date Received
    March 3, 2008
    Date of Event
    October 15, 2007
    Report Date
    October 15, 2007
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTM
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RECEIVED FOR INVESTIGATION. IT WAS IN ITS ORIGINAL PACKAGING AND HAD NOT BEEN USED. OBSERVATION CONFIRMED A 'CLOUDY' MARK ON THE MANOMETER FACE. THE MARK WAS IN THE VICINITY OF THE 10 TO 25 CM H2O AREA OF THE SCALE AND WAS ABOUT 1 SQ CM IN SIZE. CLOSER EXAMINATION OF THE MARK SHOWED THAT IT WAS COMPOSED OF FINE SCRATCHES AND IT WAS ON THE OUTSIDE OF THE MANOMETER GLASS (AS OPPOSED TO THE INSIDE WHICH WAS REPORTED BY THE HOSPITAL). A PLASTIC POLISHING PRODUCT APPLIED TO THE OUTSIDE OF THE GLASS WAS ABLE TO REMOVE THE MARK COMPLETELY. IT IS POSSIBLE THAT THE MARK WAS MADE INADVERTENTLY DURING PRODUCTION. PRODUCTION PROCESSES HAVE BEEN REVIEWED. THIS REPORT IS BEING FILED LATE AS IT HAD BEEN DISCOVERED DURING AUDIT AS OMITTED FROM REPORTING.

    Description of Event or Problem · 1

    A HOSPITAL STATED THAT THE MANOMETER GLASS WAS MARKED INTERNALLY, MAKING IT DIFFICULT TO READ THE SCALE. THIS WAS NOT USED ON A PATIENT. FAULT WAS FOUND AT HOSPITAL STORES ON RECEIPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEOPUFF INFANT RESUSCITATOR GAS POWERED T PIECE INFANT RESUSCITATOR BTM FISHER & PAYKEL HEALTHCARE, LTD. RD900 070724

    Patients

    Seq Age Sex Outcome Treatment
    1