BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAMECA, GAS-MACHINE, ANESTHESIA

    MDR report key: 3761000 · Received April 11, 2014

    Report

    Report Number
    3010587095-2014-00008
    Event Type
    Injury
    Date Received
    April 11, 2014
    Report Date
    April 4, 2014
    Manufacturer
    PHILIPS ANESTHESIA CARE
    Product Code
    BSZ
    PMA / PMN Number
    K122063
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE USER REPORTED THAT THE DEVICE PERFORMANCE (ABNORMAL AIRFLOW) LED THE USER TO TAKE IMMEDIATE CLINICAL ACTION TO MITIGATE HEALTH RISK AT THE BEGINNING OF A SURGERY. THERE WAS NO ADVERSE IMPACT TO THE INVOLVED PT. THE AIRFLOW WAS ABNORMAL DUE TO A TWISTED HOSE. THE INFORMATION AVAILABLE REGARDING THE TWISTED HOSE IS CONSISTENT WITH A USE ERROR AFTER THE COMPLETION OF THE SELF TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221211 DAMECA, GAS-MACHINE, ANESTHESIA DAMECA, GAS-MACHINE, ANESTHESIA BSZ PHILIPS ANESTHESIA CARE 866205

    Patients

    Seq Age Sex Outcome Treatment
    1 Other