BEUDAMED
    FDA Adverse Event Other Summary report: N

    HT50 VENTILATOR

    MDR report key: 1736731 · Received June 10, 2010

    Report

    Report Number
    3003135857-2010-00007
    Event Type
    Other
    Date Received
    June 10, 2010
    Date of Event
    May 8, 2010
    Report Date
    May 20, 2010
    Manufacturer
    FLIGHT MEDICAL
    Product Code
    CBK
    PMA / PMN Number
    K082724
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    REPORTEDLY, AFTER ONE HOUR OF RUNNING ON A PT, THE UNIT GAVE DEVICE ALERT WITH AUDIBLE ALARM. THE CAREGIVER PRESSED THE RESET BUTTON AND THE AUDIBLE ALARM WAS SILENCED; HOWEVER, ALL THE DISPLAY BECAME BLANK AND THE UNIT SHUT DOWN. THE UNIT WAS UNABLE TO BE STARTED BACK UP. THE PT WAS AMBU BAGGED AND THEN SWITCHED TO ANOTHER VENTILATOR. THE UNIT WAS RUNNING ON BATTERY POWER AT THE TIME OF THIS INCIDENT, AND HAD BEEN CHARGED 3 TO 4 HOURS PRIOR TO USE. PLEASE NOTE THAT THERE WAS NO PERMANENT INJURY IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HT50 VENTILATOR CBK, NOU CBK FLIGHT MEDICAL HT50-H1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Required Intervention