BEUDAMED
    FDA Adverse Event Other Summary report: N

    HAMILTON

    MDR report key: 375643 · Received February 4, 2002

    Report

    Report Number
    375643
    Event Type
    Other
    Date Received
    February 4, 2002
    Date of Event
    January 22, 2002
    Report Date
    January 31, 2002
    Manufacturer
    HAMILTON MEDICAL INC
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT EXPERIENCED RESPIRATORY ARREST ON THE PULMONARY MEDICAL UNIT. FOLLOWING RESUSCITATION, THE PT WAS SUBSEQUENTLY TRANSFERRED TO THE CRITICAL CARE UNIT AND PLACED ON THE VENTILATOR. PT WENT INTO CARDIAC ARREST APPROX 5 MINUTES AFTER BEING PLACED ON THE VENTILATOR. PT WAS CODED FOR 45 MINUTES BUT DID NOT SURVIVE THE CODE. IT APPEARS THAT THE VENTILATOR CIRCUIT WAS NOT ASSEMBLED CORRECTLY PREVENTING THE PT FROM RECEIVING OXYGEN OR VENTILATION FROM THE MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAMILTON VENTILATOR CBK HAMILTON MEDICAL INC GALILEO *

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other