BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARK 5 NUVO LITE OXYGEN CONCENTRATOR

    MDR report key: 6547726 · Received May 5, 2017

    Report

    Report Number
    1039215-2017-00001
    Event Type
    Injury
    Date Received
    May 5, 2017
    Date of Event
    March 6, 2017
    Report Date
    May 4, 2017
    Manufacturer
    NIDEK MEDICAL PRODUCTS, INC.
    Product Code
    CAW
    PMA / PMN Number
    K123738
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS THROWN AWAY AFTER INCIDENT.

    Description of Event or Problem · 1

    "ON (B)(6), THE SON OF A PATIENT (WHO LIVES IN (B)(6)) CALLS US TO REPORT THAT THE OXYGEN CONCENTRATOR HAS BEEN SET ON FIRE AT NIGHT SUDDENLY. THE MEDICAL DEVICE WAS IN A SEPARATE ROOM (IT'S THE ONLY ROOM THAT HAS BEEN BURNED). THE SON CONFIRMS THAT THERE WAS NO SOURCE OF HEAT NEAR THE OXYGEN CONCENTRATOR. THE EQUIPMENT HAS BEEN TOTALLY BURNED." WE RECEIVED SUBSEQUENT INFORMATION AT A LATER DATE THAT "THE PATIENT INHALED SMOKE AND WAS HOSPITALIZED FOR OBSERVATION DURING LESS THAN 24H". WE REQUESTED THE DEVICE BE RETURNED TO NIDEK MEDICAL PRODUCTS, INC. AND ON (B)(6) WE WERE INFORMED THAT THE PATIENT'S SON HAD DISPOSED OF THE DEVICE AND IT WAS NOT AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330840 MARK 5 NUVO LITE OXYGEN CONCENTRATOR OXGYEN CONCENTRATOR CAW NIDEK MEDICAL PRODUCTS, INC. 925 15019

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization