BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BSZ

    MDR report key: 3709333 · Received February 25, 2014

    Report

    Report Number
    3010587095-2014-00003
    Event Type
    Malfunction
    Date Received
    February 25, 2014
    Date of Event
    January 29, 2014
    Report Date
    January 29, 2014
    Manufacturer
    PHILIPS ANESTHESIA CARE
    Product Code
    BSZ
    PMA / PMN Number
    K122063
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IN TESTING AFTER THE EVENT BOTH BY THE HOSPITAL BIOMEDICAL ENGINEER AND BY THE PHILIPS SERVICE ENGINEER, THE ANESTHESIA DEVICE HAS PERFORMED AS INTENDED AND EXPECTED. IF THIS FAILURE MODE WERE TO RECUR DURING SURGERY, IMMEDIATE CLINICAL ACTION WOULD BE NEEDED TO MITIGATE THE HEALTH RISK TO THE PATIENT. PHILIPS ANESTHESIA CARE IS INVESTIGATING FURTHER. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE USERS REPORTED THAT THIS DEVICE FAILED TO VENTILATE A PATIENT DURING SURGERY. THEY REPORTED THAT THERE WAS NO ADVERSE IMPACT TO THE PATIENT, AS THE AVAILABLE MANUAL VENTILATION WAS UTILIZED WHEN AUTOMATED VENTILATION DID NOT PROVIDE ADEQUATE VENTILATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115004 BSZ DAMECA, GAS-MACHINE, ANESTHESIA BSZ PHILIPS ANESTHESIA CARE 866205

    Patients

    Seq Age Sex Outcome Treatment
    1