BEUDAMED
    FDA Adverse Event Other Summary report: N

    HT50 VENTILATOR

    MDR report key: 1670216 · Received April 20, 2010

    Report

    Report Number
    3003135857-2010-00005
    Event Type
    Other
    Date Received
    April 20, 2010
    Date of Event
    March 22, 2010
    Report Date
    March 23, 2010
    Manufacturer
    FLIGHT MEDICAL
    Product Code
    CBK
    PMA / PMN Number
    K082724
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, THE VENTILATOR GAVE LOW BATTERY ALARM ON DC BATTERY POWER DURING USE ON A PT WHILE TRAVELING. THE PT/CAREGIVER SWITCHED TO AC POWER AND TRIED TO RECHARGE THE INTERNAL BATTERY. HOWEVER, THE VENTILATOR WOULD NOT SWITCH TO AC POWER AND THE BATTERY DID NOT RECHARGE. THE PT WAS AMBU BAGGED FOR A COUPLE OF HOURS AND THEN SWAPPED TO THE BACKUP VENTILATOR. PLEASE NOTE THAT LOW BATTERY ALARM FUNCTIONED PROPERLY IN THIS CASE. PLEASE ALSO NOTE THAT THE PT WAS AMBU BAGGED FOR A COUPLE OF HOURS BECAUSE THEIR BACKUP VENTILATOR REQUIRED A DC-AC INVERTER TO RUN AND IT TOOK TIME FOR THE CAREGIVER TO PURCHASE IT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention