BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GARBIN

    MDR report key: 2581502 · Received May 16, 2012

    Report

    Report Number
    2518422-2012-00695
    Event Type
    Malfunction
    Date Received
    May 16, 2012
    Date of Event
    April 20, 2012
    Report Date
    April 20, 2012
    Manufacturer
    RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE MFR RECEIVED INFO ALLEGING A VENTILATOR FAILED TO POWER ON. THERE WAS NO PT HARM OR INJURY REPORTED. THE DEVICE HAS YET TO BE RECEIVED BY THE MFR FOR EVAL. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MFR¿S INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GARBIN VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP 1058180

    Patients

    Seq Age Sex Outcome Treatment
    1