BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3951141 · Received July 22, 2014

    Report

    Report Number
    1525712-2014-03898
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Report Date
    June 17, 2014
    Manufacturer
    UNKNOWN
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PER PROVIDER DEALER DOES NOT HAVE A SERIAL NUMBER. STATED THE UNIT HAS LOW O2 AND SHUTS DOWN WHEN RUNNING ON THE CAR ADAPTER. DEALER STATED THERE WERE NO INJURIES ASSOCIATED WITH THE INCIDENT. THE UNIT WAS PURCHASED SECOND HAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428418 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW UNKNOWN TPO100B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other