BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAX

    MDR report key: 226774 · Received June 9, 1999

    Report

    Report Number
    226774
    Event Type
    Death
    Date Received
    June 9, 1999
    Date of Event
    May 21, 1999
    Report Date
    June 8, 1999
    Manufacturer
    HAMILTON MEDICAL
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PT WAS BEING TRANSPORTED WITH VENTILATOR (HAMILTON MEDICAL MODEL "MAX"), BY A RESPIRATORY TECH AND TWO "OR" NURSES. ALSO IN USE WERE AN EXTERNAL BREATHING CIRCUIT MONITOR AND A PULSE OXIMETER. THE RESPIRATORY TECH LEFT. PT HAD AN O2 READING OF 95%. RESP TECH TOOK THE PULSE OXIMETER WITH HER. PT EXPIRED SOON AFTER. IT IS UNK AT THIS TIME, WHAT IF ANY OTHER EQUIPMENT WAS BEING USED AT THE TIME OF THE INCIDENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death BREATHING CIRCUIT MONITOR (1/21/1999 (STOP'D)).| PULSE OXIMETER (05/21/1999 (STOP'D))