BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPUR II

    MDR report key: 1573824 · Received January 4, 2010

    Report

    Report Number
    9610691-2010-00001
    Event Type
    Malfunction
    Date Received
    January 4, 2010
    Date of Event
    November 30, 2009
    Report Date
    January 4, 2010
    Manufacturer
    AMBU A/S
    Product Code
    BTM
    PMA / PMN Number
    K042682
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR INSPECTION, AND IT WAS CONFIRMED THAT THE VALVE DISC WAS MISSING. ALL PRODUCTS SHALL PASS FINAL INSPECTION WHICH INCLUDES FUNCTIONAL TEST THAT WILL REVEAL A DEFECT AS THE REPORTED. WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE AFFECTED PRODUCTION LOT, AND HAVE FOUND NO ABNORMALITIES. THE COMPLAINT FILES HAS BEEN REVIEWED AS WELL AND NO SIMILAR DEFECTS HAVE BEEN REPORTED. THEREFORE, WE REGARD THIS AS AN ISOLATED EVENT AND ARE NOT ABLE TO IDENTIFY THE ROOT CAUSE OF REPORTED PROBLEM. IN THE INSTRUCTIONS FOR USE THE FOLLOWING IS DESCRIBED: BEFORE PLACING THE PRODUCT "READY FOR USE" IN EMERGENCY SITUATIONS 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.

    Description of Event or Problem · 1

    DURING AN ATTEMPT TO REVIVE THE PATIENT, IT WAS DISCOVERED THE SPUR II WAS NOT PROVIDING OXYGEN TO THE PATIENT AND NOTED THAT THE FLUTTER VALVE WAS MISSING. A SECOND SPUR II WAS USED WITHOUT INCIDENT, BUT PATIENT DID NOT REVIVE. AFTER FULL INVESTIGATION BY (B)(6), IT WAS NOTED THE INCIDENT DID NOT CONTRIBUTE TO PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPUR II SINGLE PATIENT USE RESUSCITATOR BTM AMBU A/S ADULT 1105939

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK