BEUDAMED
    FDA Adverse Event Other Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 2120494 · Received June 3, 2011

    Report

    Report Number
    1525712-2011-00233
    Event Type
    Other
    Date Received
    June 3, 2011
    Date of Event
    April 20, 2011
    Report Date
    June 2, 2011
    Manufacturer
    INVACARE
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SERIOUS INJURY ALLEGED. DEALER WAS TESTING THE NEW UNIT AND STATED THE UNIT GOT HOT AND SHUT DOWN. THE CONCENTRATOR HAS VARIOUS SERVICE ALARMS AND SAFETY FEATURES. THE CONCENTRATOR'S COMPRESSOR IS THERMAL PROTECTED WITH A SHUTDOWN FEATURE. THE CONCENTRATOR HAS A COOLING FAN, WHICH IF DAMAGED WILL ALARM AND/OR SHUT DOWN. MANUFACTURER IS WORKING TO OBTAIN THE CONCENTRATOR FOR EVALUATION. MALFUNCTION IS NOT CONFIRMED. FILING SOLELY ON DEALERS STATEMENT THAT THE CONCENTRATOR RUNS AND SMELLS HOT. (B)(6) 2012 - (B)(6) - THE INITIAL WAS FILED UNDER (B)(4) - INVACARE HQ. THIS EVENT SHOULD BE FILED UNDER (B)(4) - INVACARE (B)(4). (B)(6) 2012 - (B)(6) - THE PRODUCT WAS RETURNED FOR EVALUATION. CONDITION OF RETURN: THE CONCENTRATOR WAS USED WITH 21.97 HOURS SHOWING ON THE HOUR METER. ONE OF THE PRONGS ON THE POWER CORD WAS BENT AND THERE WAS A NICK IN THE POWER CORD NEAR THE BASE. THE CONTROL PANEL WAS DIRTY. REASON FOR RETURN: THE DEALER ALLEGES THAT WILE TESTING THE NEW UNIT, THE CONCENTRATOR ALLEGEDLY GOT EXTREMELY HOT TO THE TOUCH AND THEN SHUT DOWN. THE DEALER ALLEGEDLY OPEN THE UNIT TO GET THE SERIAL NUMBER AND ALLEGEDLY SMELLED BURNING PLASTIC. NO INJURY IS ALLEGED. RESULT ANALYSIS: VISUAL: THE CONCENTRATOR WAS IN GOOD CONDITION WITH THE EXCEPTION OF THE ABOVE MENTIONED ITEMS. FUNCTIONAL: THE CONCENTRATOR WAS POWERED ON AND OPERATED FOR APPROXIMATELY ONE HOUR. THE YELLOW LIGHT CAME ON INDICATING LOW O2. THE UNIT DID NOT SHUT DOWN, BUT BEGAN TO GET WARM TO THE TOUCH DURING OPERATION AND THERE WAS A SMELL OF PLASTIC. FURTHER INVESTIGATION FOUND THAT ONE OF THE WIRES FROM THE PC BOARD TO THE FAN WIRE HARNESS WAS MISSING. THIS CAUSED THE FAN TO BE INOPERABLE AND THUS NOT COOL THE UNIT. THE MISSING WIRE WAS INSTALLED AND THE UNIT POWERED ON AND PRODUCED O2 = 92.5%. CONCLUSION: THE CONCENTRATOR DID GET WARM DURING OPERATION DUE TO THE MISSING WIRE TO THE FAN;. THIS IS AN ASSEMBLY ISSUE. ALL UNITS ARE BEING SUBJECTED TO A 100% INSPECTION/PULL ON ALL WIRE CONNECTIONS PRIOR TO GOING TO TUNE/TEST. THIS PRACTICE WAS EFFECTIVE (B)(4) 2011. THIS CONCENTRATOR WAS PRODUCED PRIOR TO THIS DATE.

    Additional Manufacturer Narrative · 1

    NO SERIOUS INJURY ALLEGED. DEALER WAS TESTING THE NEW UNIT AND STATED THE UNIT GOT HOT AND SHUT DOWN. THE CONCENTRATOR HAS VARIOUS SERVICE ALARMS AND SAFETY FEATURES. THE CONCENTRATOR'S COMPRESSOR IS THERMAL PROTECTED WITH A SHUTDOWN FEATURE. THE CONCENTRATOR HAS A COOLING FAN, WHICH IF DAMAGED WILL ALARM AND/OR SHUT DOWN. MANUFACTURER IS WORKING TO OBTAIN THE CONCENTRATOR FOR EVALUATION. MALFUNCTION IS NOT CONFIRMED. FILING SOLELY ON DEALER'S STATEMENT THAT THE CONCENTRATOR RUNS AND SMELLS HOT.

    Description of Event or Problem · 1

    THE DEALER STATES WHILE TESTING THE NEW UNIT, THE CONCENTRATOR ALLEGEDLY GOT EXTREMELY HOT TO THE TOUCH AND THEN SHUT DOWN. THE DEALER OPENED THE UNIT TO GET THE SERIAL NUMBER AND ALLEGEDLY SMELLED BURNING PLASTIC. NO INJURY IS ALLEGED.

    Description of Event or Problem · 1

    THE DEALER STATES WHILE TESTING THE NEW UNIT, THE CONCENTRATOR ALLEGEDLY GOT EXTREMELY HOT TO THE TOUCH AND THEN SHUT DOWN. THE DEALER OPENED THE UNIT TO GET THE SERIAL NUMBER AND ALLEGEDLY SMELLED BURNING PLASTIC. 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 IRC5PO2W

    Patients

    Seq Age Sex Outcome Treatment
    1