BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT50 VENTILATOR

    MDR report key: 1874578 · Received September 28, 2010

    Report

    Report Number
    3003135857-2010-00015
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Date of Event
    August 31, 2010
    Report Date
    August 31, 2010
    Manufacturer
    FLIGHT MEDICAL
    Product Code
    CBK
    PMA / PMN Number
    K082724
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IS NOT YET COMPLETED. EVALUATION RESULTS ARE ANTICIPATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING HOME USE, THE VENTILATOR DISPLAYED A SYSTEM ERROR CODE, ALARMED AND SHUT DOWN. ATTEMPT TO AUTO-START VENTILATOR WAS NOT SUCCESSFUL. THE VENTILATOR WAS UNPLUGGED AND THEN THE ALARM STOPPED. THE VENTILATOR WAS REPLACED WITH A BACK-UP UNIT. THE PATIENT USES MOUTH PIECE VENTILATION AND HE IS NOT TOTALLY VENTILATOR DEPENDENT. NO PATIENT ISSUES WERE REPORTED. NO MEDICAL INTERVENTION WAS REQUIRED. NO PERMANENT PATIENT INJURY OCCURRED AS A RESULT OF THIS EVENT.

    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 UNK