BEUDAMED
    FDA Adverse Event Other Summary report: N

    HT50 VENTILATOR

    MDR report key: 1901733 · Received October 14, 2010

    Report

    Report Number
    3003135857-2010-00018
    Event Type
    Other
    Date Received
    October 14, 2010
    Date of Event
    September 14, 2010
    Report Date
    September 14, 2010
    Manufacturer
    FLIGHT MEDICAL
    Product Code
    CBK
    PMA / PMN Number
    K082724
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR WAS PLUGGED INTO THE AC OUTLET OVERNIGHT WHILE THE PATIENT SLEPT AT HOME. THE NEXT MORNING THE CAREGIVER DISCOVERED THAT THE UNIT WAS FUNCTIONING ONLY ON BATTERY POWER AND NOT AC. THE DEVICE HAD ALARMED AS EXPECTED. THE BATTERY POWER WAS LOW AND IT APPEARED THAT THE BATTERY WAS NOT RECHARGING. ANOTHER POWER CORD WAS ATTACHED TO VENTILATOR AND THE UNIT WAS PLUGGED INTO AC, BUT VENT STILL ONLY FUNCTIONED ON BATTERY. OTHER WALL OUTLETS WERE ALSO TRIED BUT UNIT DID NOT DETECT AC POWER. THE PATIENT WAS MANUALLY VENTILATED WHILE HE WAS TRANSFERRED TO ANOTHER VENTILATOR. IT WAS REPORTED THAT HIS VITAL SIGNS WERE STABLE. NO SERIOUS PATIENT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention