BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 2874320 · Received December 14, 2012

    Report

    Report Number
    1031452-2012-00414
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Report Date
    November 15, 2012
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - FOLLOW UP #001. INITIAL (B)(4) ISSUED MFR. REPORT # 1031452-2012-00414. THIS WAS A NON REPORTABLE COMPLAINT. THE NOZZLE ON AN IRC5PO2 CONCENTRATOR ALLEGEDLY BROKE OFF. THE UNIT WAS SENT TO INVACARE FOR REPAIR. THIS IS NOT A LIFT SUPPORT / SUSTAINING DEVICE. THE USER HAS AN ALTERNATE SOURCE OF OXYGEN TO UTILIZE WHILE REPAIRS ARE BEING MADE TO THEIR MAIN UNIT.

    Description of Event or Problem · 1

    DEALER STATES NOZZLE IS BROKEN. A CALL WAS PLACED FOR INFORMATION IT WAS LEARNED THAT THE TUBING GETS BRITTLE AND THEN THE NOZZLE BREAKS OFF. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other