BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 2150266 · Received July 6, 2011

    Report

    Report Number
    1525712-2011-00312
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    June 3, 2011
    Report Date
    August 15, 2011
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. MDR FILED. THE (B)(4) BARIATRIC BED FOOT SN (B)(4) ALLEGEDLY SPARKED WHEN IT WAS PLUGGED INTO THE OUTLET. THE BED IS APPROXIMATELY 4 YEARS OLD. IT IS UNKNOWN WHY THE PLUG WAS NOT PLUGGED INTO THE OUTLET IN THE FIRST PLACE AND HAD TO BE REINSERTED INTO THE OUTLET. IT IS UNKNOWN IF THE SPARK OCCURRED AT THE WALL OR THE JUNCTION BOX ON THE BED. IT IS UNKNOWN IF THE INSTALLATION OF THE BED AND CORD WERE BEING DONE BY A TRAINED INSTALLATION REPRESENTATIVE OR A LAYPERSON [NOTE: ONLY TRAINED PERSONNEL SHOULD BE INSTALLING THIS BED]. MAINTENANCE HISTORY ON THIS BED IS UNKNOWN. IT IS UNKNOWN IF THE BED OR ELECTRICAL OUTLET HAVE BEEN EXPOSED TO LIQUIDS OR BODILY FLUIDS. IT IS UNKNOWN IF THE PLUG PRONGS WERE MISSHAPEN OR MISSING. IT IS UNKNOWN IF THE CORD WITH THE ATTACHED PLUG IS FRAYED, TWISTED, OR CUT. IT IS UNKNOWN IF THERE HAVE BEEN OTHER RELATED ISSUES WITH THE SAME OUTLET ON OTHER DEVICES. IT IS UNKNOWN IF THERE WERE OTHER CORDS PLUGGED INTO THE SAME OUTLET. PRODUCT RETURN HAS BEEN REQUESTED. IF RETURNED, THEN FURTHER INVESTIGATION WILL BE PERFORMED. (B)(4) - INVACARE PROVIDED THE INITIAL MDR ON INVACARE (B)(4)'S BEHALF. (B)(4) - THE BED WAS RETURNED ON (B)(4) - A VISUAL AND MECHANICAL TEST WAS PERFORMED ON THE DEVICE. VISUALLY THERE WERE NO BURN MARKS FOUND ON THE DEVICE - SPECIFICALLY THE MOTORS AND CROSS CABLE CONNECTIONS. FUNCTIONALLY, A KNOWN GOOD MOTOR WAS ATTACHED TO THE CROSS CABLE AND THE POWER CORD WAS PLUGGED INTO THE WALL. THE PENDANT BUTTONS WERE PRESSED TO ARTICULATE EACH OF THE MOTORS AND NONE OF THEM OPERATED. THE CONTROL BOX ON THE FOOT SECTION WAS REPLACED WITH A KNOWN GOOD MOTOR. THE POWER CORD WAS PLUGGED INTO THE WALL OUTLET. THEN THE PENDENT BUTTONS WERE PRESSED. ALL 3 MOTORS FUNCTIONED AS INTENDED AND NO SPARKS WERE OBSERVED. THE CONTROL BOX APPEARS TO HAVE SHORTED FROM AN EXTERNAL SOURCE OF VOLTAGE. (B)(4) - CORRECTION: THE INITIAL REPORTER WAS INCORRECT. INITIALLY, (B)(6) WAS LISTED. IT WAS ACTUALLY (B)(6).

    Additional Manufacturer Narrative · 1

    NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. MDR FILED. THE BAR5490IVC BARIATRIC BED FOOT SN (B)(4) ALLEGEDLY SPARKED WHEN IT WAS PLUGGED INTO THE OUTLET. THE BED IS APPROXIMATELY 4 YEARS OLD. IT IS UNKNOWN WHY THE PLUG WAS NOT PLUGGED INTO THE OUTLET IN THE FIRST PLACE AND HAD TO BE REINSERTED INTO THE OUTLET. IT IS UNKNOWN IF THE SPARK OCCURRED AT THE WALL OR THE JUNCTION BOX ON THE BED. IT IS UNKNOWN IF THE INSTALLATION OF THE BED AND CORD WERE BEING DONE BY A TRAINED INSTALLATION REPRESENTATIVE OR A LAYPERSON [NOTE: ONLY TRAINED PERSONNEL SHOULD BE INSTALLING THIS BED]. MAINTENANCE HISTORY ON THIS BED IS UNKNOWN. IT IS UNKNOWN IF THE BED OR ELECTRICAL OUTLET HAVE BEEN EXPOSED TO LIQUIDS OR BODILY FLUIDS. IT IS UNKNOWN IF THE PLUG PRONGS WERE MISSHAPEN OR MISSING. IT IS UNKNOWN IF THE CORD WITH THE ATTACHED PLUG IS FRAYED, TWISTED, OR CUT. IT IS UNKNOWN IF THERE HAVE BEEN OTHER RELATED ISSUES WITH THE SAME OUTLET ON OTHER DEVICES. IT IS UNKNOWN IF THERE WERE OTHER CORDS PLUGGED INTO THE SAME OUTLET. PRODUCT RETURN HAS BEEN REQUESTED. IF RETURNED, THEN FURTHER INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    THE UNIT ALLEGEDLY SPARKED WHEN IT WAS PLUGGED IN. NO INJURY IS ALLEGED.

    Description of Event or Problem · 1

    THE UNIT ALLEGEDLY SPARKED WHEN IT WAS PLUGGED IN. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL INVACARE FLORIDA OPERATIONS BAR5490IVC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other