BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPUR II

    MDR report key: 1719469 · Received March 25, 2010

    Report

    Report Number
    9610691-2010-00002
    Event Type
    Malfunction
    Date Received
    March 25, 2010
    Date of Event
    January 11, 2010
    Report Date
    March 22, 2010
    Manufacturer
    AMBU A/S
    Product Code
    BTM
    PMA / PMN Number
    K042682
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES HAVE NOT BEEN RETURNED TO AMBU INC. DESPITE SEVERAL ATTEMPTS FROM AMBU TO GET IN CONTACT WITH THE COMPLAINANT. IT HAS, THEREFORE, NOT BEEN POSSIBLE TO EVALUATE THE SAID PRODUCTS. ABOUT THE PRODUCT: ALL PRODUCTS SHALL PASS FINAL INSPECTION BEFORE BEING RELEASED, WHICH INCLUDES FUNCTIONAL TEST THAT WILL REVEAL A DEFECT AS THE REPORTED. WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE AFFECTED PRODUCTION LOTS, AND HAVE FOUND NO ABNORMALITIES. IN THE INSTRUCTIONS FOR USE THE FOLLOWING IS DESCRIBED: BEFORE PLACING THE PRODUCT "READY FOR USE" IN EMERGENCY SITUATION A FUNCTIONAL TEST MUST BE PERFORMED. THE INTEGRITY OF KITS ISSUED FOR STORAGE "READY FOR USE" SHOULD BE INSPECTED AT THE INTERVAL ESTABLISHED BY LOCAL PROTOCOLS. BY FOLLOWING THESE DIRECTIONS AND PERFORMING THE PRESCRIBED FUNCTION TESTS THE REPORTED PRODUCT PROBLEM WILL BE FOUND AND THE PRESCRIBED BACK-UP PROCEDURE SHALL BE USED. ADD'L DEVICE MANUFACTURE DATE: 10/30/2008.

    Description of Event or Problem · 1

    INFO FROM MAUDE-REPORT MADE AVAILABLE TO AMBU INC FEB 23, 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPUR II SINGLE PT USE RESUSCITATOR BTM AMBU A/S SPUR II, ADULT/CHILD 1091040/1086096

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other