BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 2880538 · Received December 19, 2012

    Report

    Report Number
    1031452-2012-00457
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Report Date
    December 19, 2012
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO RMA HAS BEEN INITIATED FOR THIS ISSUE. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. CONSUMER STATES THAT THE XPO2 WILL PUT OUT OXYGEN FOR ABOUT A MINUTE AND THEN THE UNIT SHUTS COMPLETELY OFF. FOLLOW UP CALL: SPOKE WITH CONSUMER WHO STATED TECH CAME OUT AND LOOKED AT THE UNIT AND SAID THE PROBLEM WAS THEY WERE NOT CHARGING THE UNIT LONG ENOUGH. THERE WAS A SMALL BACKUP PORTABLE UNIT AVAILABLE. NOW THAT THEY ARE CHARGING THE CORRECT TIME EVERYTHING IS WORKING FINE. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS XPO100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other