BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONC.DEMO UNIT F/IOH2SHOW HFII

    MDR report key: 4790165 · Received May 22, 2015

    Report

    Report Number
    3008262382-2015-01249
    Event Type
    Death
    Date Received
    May 22, 2015
    Date of Event
    April 18, 2015
    Report Date
    April 27, 2015
    Manufacturer
    INVACARE REHABILITATION EQUIPMENT CO.
    Product Code
    CAW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE FOR THE PATIENT A SUPPLEMENTAL RECORD WILL BE FILED. THE PERFECT O2 IS THE SAME /SIMILAR TO A PRODUCT OR PRODUCTS WHICH ARE, OR HAVE BEEN MANUFACTURED AND/OR MARKETED BY INVACARE IN U.S.

    Description of Event or Problem · 1

    ACCORDING TO THE DEALER: NO O2 PRODUCTION FROM THE CONCENTRATOR BECAUSE OF THE ABSENCE OF FLOW. "THEY INSTALLED THE CONCENTRATOR AND PROVIDED A BOTTLE OF AN OXYGEN GAS AS EMERGENCY EQUIPMENT TO THE PATIENT. DURING THE NIGHT, AT 2 A.M THE PATIENT'S GRANDDAUGHTER HEARD THE CONCENTRATOR ALARM".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333988 CONC.DEMO UNIT F/IOH2SHOW HFII GENERATOR, OXYGEN, PORTABLE CAW INVACARE REHABILITATION EQUIPMENT CO. PERFECTO2V

    Patients

    Seq Age Sex Outcome Treatment
    1 82 Death