BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1031452-2015-14068

    MDR report key: 4818014 · Received June 4, 2015

    Report

    Report Number
    1031452-2015-14068
    Event Type
    Malfunction
    Date Received
    June 4, 2015
    Report Date
    August 7, 2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RETURNED FOR EVALUATION. DEVICE BEING EXAMINED MORE CLOSELY, EVALUATION NOT YET COMPLETED. FOLLOW UP TO BE SENT WHEN ADDITIONAL INFORMATION/EVALUATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE EMERGENCY RESPONDENT STATED THE OUTLET WAS COMPLETELY MELTED. SHE SAID THEY JUST HAD THE ELECTRIC BOX REPLACED A FEW WEEKS AGO AT HER HOUSE AND THEY ELECTRICIAN PUT IN A NEW CIRCUIT BOARD. FOLLOW UP TO BE SENT IF ADDITIONAL INFORMATION IS RECEIVED

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION WAS RETURNED AND HELD FOR A DETAILED EVALUATION, WHICH WAS COMPLETED AS OF 08/07/2015. THE RETURNS EXPANDED EVALUATION REPORT FORM (NOW ATTACHED TO THE PARENT RECORD (B)(4)) STATES THAT THE COMPLAINT OF THE POWER CORD CAUSING SPARKS AND FLAMES WAS NOT CONFIRMED AT ANY IN POINT DURING THEIR TESTING. FURTHERMORE, THE REPORT STATES "THE POWER SUPPLY ASSEMBLE COULD NOT HAVE CAUSED THE SPARKING OR RESULTING DAMAGE. THE SPARKING AND DAMAGE TO THE POWER SUPPLY PLUG PRONGS WAS MOST LIKELY CAUSED BY A DEFECT IN THE RECENTLY REPAIRED ELECTRICAL SYSTEM IN THE END USER'S HOME." FOLLOW-UP FILED. (B)(4) 2015. THE EMERGENCY RESPONDENT STATED THE OUTLET WAS COMPLETELY MELTED. SHE SAID THEY JUST HAD THE ELECTRIC BOX REPLACED A FEW WEEKS AGO AT HER HOUSE AND THEY ELECTRICIAN PUT IN A NEW CIRCUIT BOARD. FOLLOW UP TO BE SENT IF ADDITIONAL INFORMATION IS RECEIVED

    Description of Event or Problem · 1

    PROVIDER STATES THAT THE BED CORD WAS PLUGGED INTO THE OUTLET AND THERE WERE SPARKS AND FLAMES THAT CAME OUT OF THE OUTLET.

    Description of Event or Problem · 1

    PROVIDER STATES THAT THE BED CORD WAS PLUGGED INTO THE OUTLET AND THERE WERE SPARKS AND FLAMES THAT CAME OUT OF THE OUTLET

    Description of Event or Problem · 1

    PROVIDER STATES THAT THE BED CORD WAS PLUGGED INTO THE OUTLET AND THERE WERE SPARKS AND FLAMES THAT CAME OUT OF THE OUTLET.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other