BEUDAMED
    FDA Adverse Event Other Summary report: N

    HAMILTON MEDICAL GALILEO

    MDR report key: 4054576 · Received August 27, 2014

    Report

    Report Number
    2937708-2014-00001
    Event Type
    Other
    Date Received
    August 27, 2014
    Date of Event
    July 27, 2014
    Report Date
    August 27, 2014
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    PMA / PMN Number
    K080181
    Report Source
    Distributor report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RELEASE OF THE VENTILATOR FOR OFF-SITE EVALUATION WAS PROVIDED (B)(4) 2014. WE HAVE LOAN IN ROUTE TO THE HOSPITAL. THIS WILL BE INSTALLED THE WEEK OF (B)(4) 2014. THE GALILEO IN QUESTION WILL BE SHIPPED TO THE (B)(4) MANUFACTURING FACILITY IN (B)(6) AT THIS TIME.

    Description of Event or Problem · 1

    VENTILATOR SCREEN "FROZE UP" AND VENTILATION WAS INTERRUPTED. POWER HAD TO BE RECYCLED TO RESTORE NORMAL OPERATION. THE ON-SITE BIOMED STATED THAT THERE WERE "POWER ISSUES LOCALLY DUE TO STORMS." HE STATED THAT THEY HAVE NOT PROVIDED THE EXACT TIME OF THE INCIDENT BUT THINKS IT IS AROUND 9PM ON (B)(6). HE ALSO STATED THAT THE PT HAD TO BE TRANSPORTED TO ANOTHER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522527 HAMILTON MEDICAL GALILEO CONTINUOUS VENTILATOR, FACILITY USE CBK HAMILTON MEDICAL AG GALILEO

    Patients

    Seq Age Sex Outcome Treatment
    1