BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 2223295 · Received August 25, 2011

    Report

    Report Number
    1031452-2011-00003
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 25, 2011
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) HAS BEEN ISSUED FOR THE RETURN OF THIS DEVICE. IT IS UNKNOWN IF THE DEALER READ AND FULLY UNDERSTANDS THE USER MANUAL FOR MODEL XPO100 IS PART NO 1148112 REV D. PAGE 2 PROVIDES THE FOLLOWING WARNING REGARDING READING AND UNDERSTANDING THE USER MANUAL . "WARNING - DO NOT USE THIS PRODUCT OR ANY AVAILABLE OPTIONAL EQUIPMENT WITHOUT FIRST COMPLETELY READING AND UNDERSTANDING THESE INSTRUCTIONS AND ANY ADDITIONAL INSTRUCTIONAL MATERIAL SUCH AS USER MANUALS, SERVICE MANUALS OR INSTRUCTION SHEETS SUPPLIED WITH THIS PRODUCT OR OPTIONAL EQUIPMENT. IF YOU ARE UNABLE TO UNDERSTAND THE WARNINGS, CAUTIONS OR INSTRUCTIONS, CONTACT A HEALTHCARE PROFESSIONAL, DEALER OR TECHNICAL PERSONNEL BEFORE ATTEMPTING TO USE THIS EQUIPMENT - OTHERWISE, INJURY OR DAMAGE MAY OCCUR. THE DEALER DID NOT MENTION IF AN AUDIBLE ALARM SOUNDED OR ANY OF THE INDICATOR LIGHTS ILLUMINATED WHEN THE POWER CORD BECAME WARM TO THE TOUCH. INVACARE USER MANUAL PAGE 42 STATES THE FOLLOWING TROUBLESHOOTING TECHNIQUE WHEN THE CONCENTRATOR IS TOO HOT OR COLD. IT IS UNKNOWN IF THE DEALER FOLLOWED THESE INSTRUCTIONS. PAGE 42 - "SYMPTOM => CONTINUOUS AUDIBLE BEEP AND RED ALARM INDICATOR IS ILLUMINATED. FAN IS ON. AND FLOW INDICATORS 1 & 3 ARE ILLUMINATED. PROBABLE CAUSE => UNIT HAS BECOME TOO HOT, OR TOO COLD, DURING OPERATION. SOLUTION = ALLOW UNIT TO COOL DOWN TO LESS THAN 95ºF, OR WARM UP TO 50ºF, BEFORE TURNING THE UNIT ON AGAIN. IF THE ALARM CONTINUES, CHANGE TO ANOTHER SOURCE OF OXYGEN AND CONTACT YOUR EQUIPMENT PROVIDER.

    Description of Event or Problem · 1

    THE DEALER ALLEGES WHEN HE TOOK THE UNIT OUT OF THE BOX AND TURNED IT ON, THE POWER CORD WAS WARM TO THE TOUCH. NO INJURY IS ALLEGED.

    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