BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BSZ

    MDR report key: 3937200 · Received April 8, 2014

    Report

    Report Number
    3010587095-2014-00007
    Event Type
    Malfunction
    Date Received
    April 8, 2014
    Report Date
    March 14, 2014
    Manufacturer
    PHILIPS ANESTHESIA CARE
    Product Code
    BSZ
    PMA / PMN Number
    K122063
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE USER REPORTED THAT THIS DEVICE DOES NOT HAVE ELECTRICAL POWER. THERE WERE NO KNOWN ENVIRONMENTAL ELECTRICAL CONDITIONS OUTSIDE NORMAL USE CONDITIONS AT THE TIME OF THE PROBLEM. IF THIS DEVICE LOSES POWER DURING USE, ANESTHESIA AND VENTILATION WILL CONTINUE, POWERED BY THE CONNECTED DRIVE GAS SOURCE, AND THE ELECTRONICS ARE POWERED BY THE INTERNAL BACK-UP BATTERY FOR UP TO 90 MINUTES WITHOUT REDUCTION IN PERFORMANCE, BUT EXTENDED USE COULD REQUIRE SWITCHING TO MANUAL DELIVERY OR CHANGING THE ANESTHESIA SYSTEM. WE WILL CONSIDER THAT THE FAILURE OF THE FUSE COULD POSE A HEALTH RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212726 BSZ DAMECA, GAS-MACHINE, ANESTHESIA BSZ PHILIPS ANESTHESIA CARE 866205

    Patients

    Seq Age Sex Outcome Treatment
    1