BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 2193757 · Received August 5, 2011

    Report

    Report Number
    1525712-2011-00428
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 5, 2011
    Report Date
    August 5, 2011
    Manufacturer
    INVACARE
    Product Code
    CAW
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEALER ALLEGES THAT THERE WAS A BURNING SMELL DURING AN OUT OF THE BOX INSPECTION OF A CONCENTRATOR MODEL IRC5PO2C, SN (B)(4). PACKAGING AND TRANSPORTATION OF THE DEVICE WERE NOT DOCUMENTED IN THE DEALERS STATEMENT. THE USER MANUAL PN 1143482 ON PAGE 11 PROVIDES UNPACKING CHECKS FOR DAMAGE: "CHECK FOR ANY OBVIOUS DAMAGE TO THE CARTON OR ITS CONTENTS. IF DAMAGE IS EVIDENT, NOTIFY THE CARRIER", THE DEALER DID NOT STATE THAT HE NOTIFIED THE CARRIER. IN REGARDS TO THE BURNING SMELL, INVACARE HAS INCORPORATED SAFETY MECHANISMS TO SHUT THE DEVICE DOWN IF OVERHEATING OCCURS. PAGE 13 OF THE USER MANUAL LISTS THEM. THEY ARE: "CURRENT OVERLOAD OR LINE SURGE SHUTDOWN. HIGH TEMPERATURE COMPRESSOR SHUTDOWN. HIGH PRESSURE ALARM W/COMPRESSOR SHUTDOWN. LOW PRESSURE ALARM W/COMPRESSOR SHUTDOWN. BATTERY FREE POWER LOSS ALARM. SENSO2 OXYGEN SYSTEM (SENSO2 MODEL) LOW FLOW ALARM". THE DEALER DID NOT STATE IF ANY OF THESE SAFETY FEATURES WERE ACTIVATED. IN ADDITION, THE DEALER DID NOT STATE IF THE SYSTEM FAILURE INDICATORS FOR INITIAL START-UP AS SHOWN ON PAGES 21 AND 22 OF THE USER'S MANUAL WERE SEEN OR THE DEVICE SHUT DOWN. THESE INDICATORS WOULD ALERT THE CONSUMER TO OVERHEATING OF THE DEVICE. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEALER ALLEGES THAT THERE WAS A BURNING SMELL DURING AN OUT OF THE BOX INSPECTION OF A CONCENTRATOR MODEL IRC5PO2C SN (B)(4). PACKAGING AND TRANSPORTATION OF THE DEVICE WERE NOT DOCUMENTED IN THE DEALERS STATEMENT. THE USER MANUAL PN 1143482 ON PAGE 11 PROVIDES UNPACKING CHECKS FOR DAMAGE: "CHECK FOR ANY OBVIOUS DAMAGE TO THE CARTON OR ITS CONTENTS. IF DAMAGE IS EVIDENT, NOTIFY THE CARRIER." THE DEALER DID NOT STATE THAT HE NOTIFIED THE CARRIER. IN REGARDS TO THE BURNING SMELL, INVACARE HAS INCORPORATED SAFETY MECHANISMS TO SHUT THE DEVICE DOWN IF OVERHEATING OCCURS. PAGE 13 OF THE USER MANUAL LISTS THEM. THEY ARE: "CURRENT OVERLOAD OR LINE SURGE SHUTDOWN. HIGH TEMPERATURE COMPRESSOR SHUTDOWN. HIGH PRESSURE ALARM W/COMPRESSOR SHUTDOWN. LOW PRESSURE ALARM W/COMPRESSOR SHUTDOWN. BATTERY FREE POWER LOSS ALARM. SENSO2 OXYGEN SYSTEM (SENSO2 MODEL) LOW FLOW ALARM." THE DEALER DID NOT STATE IF ANY OF THESE SAFETY FEATURES WERE ACTIVATED. IN ADDITION, THE DEALER DID NOT STATE IF THE SYSTEM FAILURE INDICATORS FOR INITIAL START-UP AS SHOWN ON PAGES 21 AND 22 OF THE USER'S MANUAL WERE SEEN OR THE DEVICE SHUT DOWN. THESE INDICATORS WOULD ALERT THE CONSUMER TO OVERHEATING OF THE DEVICE.

    Description of Event or Problem · 1

    THE UNIT ALLEGEDLY HAD A BURNT SMELL WHEN THE DEALER PLUGGED IT IN AND POWERED IT ON. NO INJURY IS ALLEGED.

    Description of Event or Problem · 1

    THE UNIT ALLEGEDLY HAD A BURNT SMELL WHEN THE DEALER PLUGGED IT IN AND POWERED IT ON. 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 IRC5PO2

    Patients

    Seq Age Sex Outcome Treatment
    1