BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GARBIN I VENTILATOR

    MDR report key: 3061461 · Received April 10, 2013

    Report

    Report Number
    2518422-2013-00542
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 25, 2013
    Manufacturer
    RESPIRONICS INC.
    Product Code
    CBK
    PMA / PMN Number
    K082526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE VENTILATOR WAS RETURNED TO A THIRD PARTY SERVICE CENTER FOR EVALUATION AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE DEVICE'S POWER SUPPLY WAS REPLACED TO ADDRESS THE ISSUE.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFO FROM A THIRD PARTY SERVICE CENTER ALLEGING A VENTILATOR WOULD NOT POWER ON. THERE WAS NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153396 GARBIN I VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS INC. 1058180

    Patients

    Seq Age Sex Outcome Treatment
    1