BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 2243369 · Received September 12, 2011

    Report

    Report Number
    1031452-2011-00010
    Event Type
    Malfunction
    Date Received
    September 12, 2011
    Date of Event
    August 15, 2011
    Report Date
    November 10, 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 CONCENTRATOR. THE MODEL XPO100B (B)(4) IS APPROXIMATELY 3 MONTHS OLD. THE USER MANUAL FOR THIS DEVICE IS PART NUMBER 1148112 REV D. THE DEALER ALLEGES THAT THE DEVICE WAS OVERHEATING. THE DEVICE ALARMED [FAIL SAFE]. INVACARE HAS INCORPORATED SAFETY MECHANISMS TO SHUT THE DEVICE DOWN IF OVERHEATING OCCURS. THE USER MANUAL LISTS THEM: ON PG34- "SYSTEM TOO HOT/COLD FOR START ALARM - IF THE INTERNAL SENSORS REGISTER TEMPERATURES OUTSIDE FACTORY SET LEVELS UPON START-UP, THE UNIT WILL ALARM WITH A RAPID AUDIBLE BEEP, THE RED ALARM INDICATOR LIGHT WILL ILLUMINATE CONTINUOUSLY, THE UNIT WILL NOT OPERATE AND THE FLOW SETTING 1 & 2 BLUE INDICATOR LIGHTS WILL ILLUMINATE. THE FAN WILL TURN ON. ALLOW THE UNIT TO COOL OR WARM TO THE RECOMMENDED OPERATING TEMPERATURE RANGE (SEE RECOMMENDATIONS FOR OPTIMAL PERFORMANCE ON PAGE 18). TURN OFF THE UNIT AND TRY AGAIN. CHANGE TO AN ALTERNATE SOURCE OF OXYGEN WHILE WAITING. IF THE ALARM CONTINUES, CONTACT YOUR EQUIPMENT PROVIDER." ON PG35- "SYSTEM TOO HOT/COLD RUNNING ALARM - IF THE INTERNAL SENSORS REGISTER TEMPERATURES OUTSIDE FACTORY SET LEVELS DURING OPERATION, THE UNIT WILL ALARM WITH A RAPID AUDIBLE BEEP, THE RED ALARM INDICATOR LIGHT WILL ILLUMINATE CONTINUOUSLY, THE UNIT WILL NOT OPERATE AND THE FLOW SETTING 1 & 3 BLUE INDICATOR LIGHTS WILL ILLUMINATE. THE FAN WILL TURN ON. ALLOW THE UNIT TO COOL OR WARM TO THE RECOMMENDED OPERATING TEMPERATURE RANGE (SEE RECOMMENDATIONS FOR OPTIMAL PERFORMANCE ON PAGE 18). TURN OFF THE UNIT AND TRY AGAIN. CHANGE TO AN ALTERNATE SOURCE OF OXYGEN WHILE WAITING. IF THE ALARM CONTINUES, CONTACT YOUR EQUIPMENT PROVIDER." ON PG35- "BATTERY TOO HOT/COLD ALARM - IF THE INTERNAL BATTERY SENSOR REGISTERS TEMPERATURE OUTSIDE A FACTORY DEFINED TEMPERATURE RANGE WHILE THE UNIT IS OPERATING, THE UNIT WILL ALARM WITH A RAPID AUDIBLE BEEP, THE RED ALARM INDICATOR LIGHT WILL ILLUMINATE CONTINUOUSLY, THE UNIT WILL STOP RUNNING AND THE FLOW SETTING 1 & 4 BLUE INDICATOR LIGHTS WILL ILLUMINATE. TURN OFF THE UNIT AND DISCONNECT AC OR DC POWER ADAPTERS. ALLOW TO THE UNIT TO COOL OR WARM, TO THE RECOMMENDED OPERATING TEMPERATURE RANGE (SEE RECOMMENDATIONS FOR OPTIMAL PERFORMANCE ON PAGE 18) AND TRY AGAIN. CHANGE TO AN ALTERNATE SOURCE OF OXYGEN WHILE WAITING. IF THE ALARM CONTINUES, CONTACT YOUR EQUIPMENT PROVIDER." THESE FAIL SAFES ARE TO BRING ATTENTION TO THE DEVICE. THE ALARM PERFORMED AS EXPECTED.

    Additional Manufacturer Narrative · 1

    RMA (B)(4) HAS BEEN ISSUED FOR THE RETURN OF THIS CONCENTRATOR. THE MODEL XPO100B SN (B)(4) IS APPROXIMATELY 3 MONTHS OLD. THE USER MANUAL FOR THIS DEVICE IS PART NUMBER 1148112 REV D. THE DEALER ALLEGES THAT THE DEVICE WAS OVERHEATING. THE DEVICE ALARMED [FAIL SAFE]. INVACARE HAS INCORPORATED SAFETY MECHANISMS TO SHUT THE DEVICE DOWN IF OVERHEATING OCCURS. THE USER MANUAL LISTS THEM: ON PG34- "SYSTEM TOO HOT/COLD FOR START ALARM - IF THE INTERNAL SENSORS REGISTER TEMPERATURES OUTSIDE FACTORY SET LEVELS UPON START-UP, THE UNIT WILL ALARM WITH A RAPID AUDIBLE BEEP, THE RED ALARM INDICATOR LIGHT WILL ILLUMINATE CONTINUOUSLY, THE UNIT WILL NOT OPERATE AND THE FLOW SETTING 1 & 2 BLUE INDICATOR LIGHTS WILL ILLUMINATE. THE FAN WILL TURN ON. ALLOW THE UNIT TO COOL OR WARM TO THE RECOMMENDED OPERATING TEMPERATURE RANGE (SEE RECOMMENDATIONS FOR OPTIMAL PERFORMANCE ON PAGE 18). TURN OFF THE UNIT AND TRY AGAIN. CHANGE TO AN ALTERNATE SOURCE OF OXYGEN WHILE WAITING. IF THE ALARM CONTINUES, CONTACT YOUR EQUIPMENT PROVIDER." ON PG35- "SYSTEM TOO HOT/COLD RUNNING ALARM - IF THE INTERNAL SENSORS REGISTER TEMPERATURES OUTSIDE FACTORY SET LEVELS DURING OPERATION, THE UNIT WILL ALARM WITH A RAPID AUDIBLE BEEP, THE RED ALARM INDICATOR LIGHT WILL ILLUMINATE CONTINUOUSLY, THE UNIT WILL NOT OPERATE AND THE FLOW SETTING 1 & 3 BLUE INDICATOR LIGHTS WILL ILLUMINATE. THE FAN WILL TURN ON. ALLOW THE UNIT TO COOL OR WARM TO THE RECOMMENDED OPERATING TEMPERATURE RANGE (SEE RECOMMENDATIONS FOR OPTIMAL PERFORMANCE ON PAGE 18). TURN OFF THE UNIT AND TRY AGAIN. CHANGE TO AN ALTERNATE SOURCE OF OXYGEN WHILE WAITING. IF THE ALARM CONTINUES, CONTACT YOUR EQUIPMENT PROVIDER. " ON PG35- "BATTERY TOO HOT/COLD ALARM - IF THE INTERNAL BATTERY SENSOR REGISTERS TEMPERATURE OUTSIDE A FACTORY DEFINED TEMPERATURE RANGE WHILE THE UNIT IS OPERATING, THE UNIT WILL ALARM WITH A RAPID AUDIBLE BEEP, THE RED ALARM INDICATOR LIGHT WILL ILLUMINATE CONTINUOUSLY, THE UNIT WILL STOP RUNNING AND THE FLOW SETTING 1 & 4 BLUE INDICATOR LIGHTS WILL ILLUMINATE. TURN OFF THE UNIT AND DISCONNECT AC OR DC POWER ADAPTERS. ALLOW TO THE UNIT TO COOL OR WARM, TO THE RECOMMENDED OPERATING TEMPERATURE RANGE (SEE RECOMMENDATIONS FOR OPTIMAL PERFORMANCE ON PAGE 18) AND TRY AGAIN. CHANGE TO AN ALTERNATE SOURCE OF OXYGEN WHILE WAITING. IF THE ALARM CONTINUES, CONTACT YOUR EQUIPMENT PROVIDER." THESE FAIL SAFES ARE TO BRING ATTENTION TO THE DEVICE. THE ALARM PERFORMED AS EXPECTED. (B)(4) EVALUATION COMPLETED. NO ISSUE FOUND. THE CONCENTRATOR PERFORMED AS DESIGNED.

    Description of Event or Problem · 1

    THE CONSUMER ALLEGES THE UNIT WAS VERY HOT. THE CHARGER WAS REPLACED. THE CONSUMER ALLEGES THE UNIT IS STILL GETTING HOT, SMELLS HOT, AND THEN THE UNIT ALARMED. THE DEALER WENT TO PICK THE UNIT UP AND ALLEGES THE SIDE OF THE UNIT APPEARED TO BE MELTED. NO INJURY IS ALLEGED.

    Description of Event or Problem · 1

    THE CONSUMER ALLEGES THE UNIT WAS VERY HOT. THE CHARGER WAS REPLACED. THE CONSUMER ALLEGES THE UNIT IS STILL GETTING HOT, SMELLS HOT, AND THEN THE UNIT ALARMED. THE DEALER WENT TO PICK THE UNIT UP AND ALLEGES THE SIDE OF THE UNIT APPEARED TO BE MELTED. 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 XPO100B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other