BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 2895691 · Received January 3, 2013

    Report

    Report Number
    1031452-2013-00006
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    November 26, 2012
    Report Date
    January 2, 2013
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    IN SPEAKING WITH THE END USER, IT WAS REPORTED SHE THOUGHT SOMETHING WAS ODD ABOUT THE CONCENTRATOR, HAD TRIED TO TURN IT UP DUE TO NEEDING MORE AIR AND SHE WAS UNABLE TO GET IT. SHE TRIED TO TURN IT UP BUT IT WOULD NOT GO OVER 2.5 LITERS AND IT WOULD WORK ITS WAY BACK DOWN. THE END USER HAS HAD THIS CONCENTRATOR FOR ABOUT 3 MONTHS AND NEVER NEEDED MORE AIR BEFORE. SHE DOES NOT KNOW IF THIS HAS BEEN A PROBLEM FROM THE BEGINNING OR NOT. THE END USER HAD HER DAUGHTER CALL AN AMBULANCE TO PICK HER UP DUE TO NOT BEING ABLE TO BREATHE. SHE RECEIVED AIR FROM THE PARAMEDICS. SHE REPORTED HER HEART WAS RUSHING AND HAD PAIN IN HER SIDES DUE TO COUGHING FROM NOT ENOUGH AIR. THE OPERATORS MANUAL INCLUDES THE FOLLOWING: INVACARE RECOMMENDS AN ALTERNATE SOURCE OF SUPPLEMENTAL OXYGEN IN THE EVENT OF A POWER OUTAGE, ALARM CONDITION OR MECHANICAL FAILURE. CONSULT YOUR PHYSICIAN OR EQUIPMENT PROVIDER FOR THE TYPE OF RESERVE SYSTEM REQUIRED. THIS EQUIPMENT IS TO BE USED AS AN OXYGEN SUPPLEMENT AND IS NOT CONSIDERED LIFE SUPPORTING OR LIFE SUSTAINING. CONSUMER AFFAIRS HAS TRIED TO LEAVE MESSAGES IN ATTEMPTS TO GATHER INFORMATION; HOWEVER, TO DATE, NO FURTHER INFORMATION HAS BEEN RECEIVED. IT WAS REPORTED THAT THE END USER HAD BEEN PROVIDED CONTACT INFORMATION FOR FURTHER ASSISTANCE WITH THE CONCENTRATOR. PLEASE NOTE THAT ANY FURTHER INFORMATION RECEIVED ON THIS INCIDENT WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    CONSUMER ALLEGES THAT THE PORTABLE OXGEN CONCENTRATOR WOULD NOT GO OVER 2 LITERS WHICH CAUSED HER TO HAVE TO BE HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3349 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5P

    Patients

    Seq Age Sex Outcome Treatment
    1 62 Hospitalization| O| R