BEUDAMED
    FDA Adverse Event Other Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 1949205 · Received December 27, 2010

    Report

    Report Number
    1525712-2010-00182
    Event Type
    Other
    Date Received
    December 27, 2010
    Date of Event
    November 13, 2010
    Report Date
    June 25, 2012
    Manufacturer
    INVACARE
    Product Code
    CAW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) ISSUED MFG REPORT #1525712-2010-00182. THE DEVICE WAS ABOUT 1 YEAR OLD AT THE TIME OF THE COMPLAINT. THE CONSUMER ALLEGES HE SMELLED AND SAW SMOKE EMITTING FROM THE UNIT. PRODUCT WAS RETURNED, A FULL EVALUATION WAS CONDUCTED ON THE UNIT. THE FINDINGS WERE: THE FOUR SEPARATE AREAS OF DAMAGE AT THE SAME TIME ARE NOT TYPICAL OF THE PC BOARD CIRCUITRY. EXTENSIVE DAMAGE OF THE CIRCUIT BOARD TRACES AND COMPONENTS ARE TYPICAL OF EITHER OVERVOLTAGE OR OVERCURRENT ON THE COMPONENTS, CAUSING CATASTROPHIC FAILURE AND THE RESULTANT FIRE/HEAT DAMAGE. THE FOUR FAILURES OF SEPARATE CIRCUITRY TENDS TO INDICATE A CASCADE FAILURE, WHERE IF ONE SECTION FAILS, THE OTHERS FAIL DUE TO INTERDEPENDENCY OF OPERATION. COMPLAINT CONFIRMED. (B)(4). NO INJURY REPORTED. CONSUMER ALLEGES THEY SAW SMELLED AND SAW SMOKE EMITTING FROM THE UNIT. THE FACILITY REPLACED THE UNIT. IT'S UNKNOWN IF A HUMIDIFIER WAS IN USE WHICH THE HUMIDITY WOULD PRODUCE A MIST LIKE VAPOR. PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION AT THIS TIME SO IT IS UNKNOWN IF A MALFUNCTION OCCURRED OR IF OTHER FACTORS SUCH AS MISUSE OR ABUSE, OR LACK OF MAINTENANCE MAY HAVE CAUSED OR CONTRIBUTED TO THIS INCIDENT. MDR FILED AS A CONSERVATIVE MEASURE.

    Additional Manufacturer Narrative · 1

    (B)(4). NO INJURY REPORTED. CONSUMER ALLEGES THEY SAW SMELLED AND SAW SMOKE EMITTING FROM THE UNIT. THE FACILITY REPLACED THE UNIT. IT'S UNKNOWN IF A HUMIDIFIER WAS IN USE WHICH THE HUMIDITY WOULD PRODUCE A MIST LIKE VAPOR. PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION AT THIS TIME SO IT IS UNKNOWN IF A MALFUNCTION OCCURRED OR IF OTHER FACTORS SUCH AS MISUSE OR ABUSE, OR LACK OF MAINTENANCE MAY HAVE CAUSED OR CONTRIBUTED TO THIS INCIDENT. MDR FILED AS A CONSERVATIVE MEASURE.

    Additional Manufacturer Narrative · 1

    NO INJURY REPORTED. CONSUMER ALLEGES THEY SAW SMELLED AND SAW SMOKE EMITTING FROM THE UNIT. THE FACILITY REPLACED THE UNIT. IT IS UNKNOWN IF A HUMIDIFIER WAS IN USE WHICH THE HUMIDITY WOULD PRODUCE A MIST LIKE VAPOR. PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION AT THIS TIME SO IT IS UNKNOWN IF A MALFUNCTION OCCURRED OR IF OTHER FACTORS SUCH AS MISUSE OR ABUSE, OR LACK OF MAINTENANCE MAY HAVE CAUSED OR CONTRIBUTED TO THIS INCIDENT. MDR FILED AS A CONSERVATIVE MEASURE.

    Description of Event or Problem · 1

    THE CONSUMER ALLEGES, HE SMELLED AND SAW SMOKE EMITTING FROM THE UNIT. NO INJURY IS ALLEGED.

    Description of Event or Problem · 1

    THE CONSUMER ALLEGES HE SMELLED AND SAW SMOKE EMITTING FROM THE UNIT. NO INJURY IS ALLEGED.

    Description of Event or Problem · 1

    THE CONSUMER ALLEGES HE SMELLED AND SAW SMOKE EMITTING FROM THE UNIT. 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 TPO100B

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other