BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BSZ

    MDR report key: 3823834 · Received May 2, 2014

    Report

    Report Number
    3010587095-2014-00010
    Event Type
    Malfunction
    Date Received
    May 2, 2014
    Report Date
    March 21, 2014
    Manufacturer
    PHILIPS ANESTHESIA CARE
    Product Code
    BSZ
    PMA / PMN Number
    K122063
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE USERS REPORTED THAT INTERNAL OXYGEN TUBE CAME OFF AT THE MANOMETER SIDE OF THE ANESTHESIA SYSTEM. THIS CAUSED A HUGE BANG AND LEAKING O2. THERE HAVE BEEN NO DEVICES DELIVERED TO ANY CUSTOMERS IN THE U.S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264874 BSZ DAMECA, GAS-MACHINE, ANESTHESIA BSZ PHILIPS ANESTHESIA CARE 866205

    Patients

    Seq Age Sex Outcome Treatment
    1