BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KSS CAPNO-FLO

    MDR report key: 754476 · Received October 21, 2005

    Report

    Report Number
    2936999-2005-00432
    Event Type
    Malfunction
    Date Received
    October 21, 2005
    Date of Event
    October 1, 2005
    Report Date
    October 5, 2005
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT RETURNING FOR EVALUATION, PRODUCT WAS NOT SAVED. THE MANUFACTURING SITE HAS OPENED A CAPA 392-05-015 TO ADDRESS THIS ISSUE. EVALUATION ON SAME PART NUMBER AND LOT NUMBER WILL BE REPORTED ON MDR# 2936999-2005-00383.

    Description of Event or Problem · 1

    IT WAS REPORTED TO NELLCOR PURITAN BENNET IN 2005 BY A EMS COODINATOR THAT THE O2 CONNECTING TUBING WAS PULLING OUT OF THE PLASTIC INTAKE COLLAR. THIS WAS NOTED PRIOR TO USE ON A PATIENT. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KSS CAPNO-FLO MANUAL RESUSCITATOR BTM NELLCOR PURITAN BENNETT 3-K-4021 4166141

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other