BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BSZ

    MDR report key: 3807969 · Received February 7, 2014

    Report

    Report Number
    3010587095-2014-00002
    Event Type
    Malfunction
    Date Received
    February 7, 2014
    Date of Event
    January 8, 2014
    Report Date
    January 8, 2014
    Manufacturer
    PHILIPS ANESTHESIA CARE
    Product Code
    BSZ
    PMA / PMN Number
    K122063
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WHILE THE PRELIMINARY ANALYSIS INDICATES THAT THERE IS MINIMAL HEALTH RISK AND THAT THE DEVICE IS PERFORMING AS INTENDED AND AS DESIGNED FOR THE SETTINGS CHOSEN, PHILIPS ANESTHESIA CARE IS INVESTIGATING FURTHER. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A PHILIPS SALESPERSON REPORTED 'WHEN USING THE NEONATAL TEST LUNG - AND NEONATAL CLINICAL SETTINGS - WE EXPERIENCED AN EVER INCREASING PRESSURE WITHOUT EVER MEETING THE SET TARGET TV. IN ADDITION, THE TV INSP AND EXPIRED VOLUMES SEEMED FROZEN, WHERE THEY REMAINED EXACTLY THE SAME, UNCHANGED, FOR UP TO 20 BREATHS OR MORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81133 BSZ DAMECA, GAS-MACHINE, ANESTHESIA BSZ PHILIPS ANESTHESIA CARE 866205

    Patients

    Seq Age Sex Outcome Treatment
    1