BEUDAMED
    FDA Adverse Event Other Summary report: N

    AMADEUS

    MDR report key: 95069 · Received June 2, 1997

    Report

    Report Number
    MW1011377
    Event Type
    Other
    Date Received
    June 2, 1997
    Date of Event
    July 2, 1996
    Manufacturer
    HAMILTON MEDICAL, INC.
    Product Code
    CBK
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    THERE WERE FOUR NEW VENTILATORS PURCHASED IN 1996. NO ADVERSE PT RESPONSE.MALFUNCTIONS PICKED UP BY RESPIRATORY THERAPISTS PRIOR TO TOTAL SYSTEM FAILURE. AMBIENT VALVE O RING FAILURE.

    Description of Event or Problem · 2

    THERE WERE FOUR NEW VENTILATORS PURCHASED IN 1996. NO ADVERSE PT RESPONSE.MALFUNCTIONS PICKED UP BY RESPIRATORY THERAPISTS PRIOR TO TOTAL SYSTEM FAILURE. PRESSURE CONTROL PROBLEM. EVENT DATE: 9/30/96.

    Description of Event or Problem · 3

    THERE WERE FOUR NEW VENTILATORS PURCHASED IN 1996. NO ADVERSE PT RESPONSE.MALFUNCTIONS PICKED UP BY RESPIRATORY THERAPISTS PRIOR TO TOTAL SYSTEM FAILURE. PEEP DOUBLE POT FAILURE. EVENT DATE: 10/9/96.

    Description of Event or Problem · 4

    THERE WERE FOUR NEW VENTILATORS PURCHASED IN 1996. NO ADVERSE PT RESPONSE.MALFUNCTIONS PICKED UP BY RESPIRATORY THERAPISTS PRIOR TO TOTAL SYSTEM FAILURE. SERVO VALVE FAILURE. EVENT DATE: 4/11/96.

    Description of Event or Problem · 5

    THERE WERE FOUR NEW VENTILATORS PURCHASED IN 1996. NO ADVERSE PT RESPONSE.MALFUNCTIONS PICKED UP BY RESPIRATORY THERAPISTS PRIOR TO TOTAL SYSTEM FAILURE. SERVO VALVE FAILURE. EVENT DATE: 4/15/97.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMADEUS VENTILATOR CBK HAMILTON MEDICAL, INC. 153032 *
    2 AMADEUS VENTILATOR CBK HAMILTON MEDICAL, INC. 153032 *
    3 AMADEUS VENTILATOR CBK HAMILTON MEDICAL, INC. 153032 *
    4 AMADEUS VENTILATOR CBK HAMILTON MEDICAL, INC. 153032 *
    5 AMADEUS VENTILATOR CBK HAMILTON MEDICAL, INC. 153032 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other
    2 NA Other
    3 NA Other
    4 NA Other
    5 NA Other