BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GARBIN I VENTILATOR

    MDR report key: 3061103 · Received April 9, 2013

    Report

    Report Number
    2518422-2013-00544
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 25, 2013
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K083526
    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. THE MALFUNCTION OF THE POWER SUPPLY WOULD RESULT IN THE FAILURE OF THE DEVICE TO OPERATE ON AC POWER OR TO CHARGE ITS INTERNAL BATTERY. THIS PARTICULAR MALFUNCTION FOR THE POWER SUPPLY HAS ONLY BEEN REPORTED ON DEVICES THAT ARE BEING SOLD INTERNATIONALLY FOR USE WITH 220 VOLT POWER SOURCES.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION 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
    147965 GARBIN I VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1058180

    Patients

    Seq Age Sex Outcome Treatment
    1