BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERFLO OXYGEN CONCENTRATOR

    MDR report key: 4220582 · Received August 6, 2014

    Report

    Report Number
    1040777-2014-00023
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 11, 2014
    Manufacturer
    RESPIRONICS INC.
    Product Code
    CAW
    PMA / PMN Number
    K061261
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE MFR RECEIVED INFO ALLEGING AN EVERFLO OXYGEN CONCENTRATOR'S POWER CORD SHORTED. THERE WAS NO REPORT OF PT HARM OR INJURY. THE INVESTIGATION IS STILL ONGOING FOR THIS ISSUE. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE MFR HAS COMPLETED THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460397 EVERFLO OXYGEN CONCENTRATOR GENERATOR, OXYGEN, PORTABLE CAW RESPIRONICS INC. 1020010

    Patients

    Seq Age Sex Outcome Treatment
    1