BEUDAMED
    FDA Adverse Event Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 4151266 · Received October 8, 2014

    Report

    Report Number
    1031452-2014-12321
    Date Received
    October 8, 2014
    Report Date
    September 16, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATED THAT HE HAD A CONSUMER THAT HAD HIS JBOX STRUCK BY LIGHTNING BECAUSE OF A LIGHTNING BOLT COMING THROUGH THE WINDOW. DEALER STATED, THAT THIS CAUSED THE JBOX TO BE FRIED RESULTING IN VISIBLE FIRE AND SMOKE. DEALER STATED THAT THIS INCIDENT HAPPENED FIVE TO SIX YEARS AGO. IN ADDITION, DEALER STATES THEY JUST HAD TO REPLACE THE JBOX AND WAS NOT A MALFUNCTION OF DEVICE. FIRE AND SMOKE WAS CONTAINED AND DID NO FURTHER DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632621 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL INVACARE FLORIDA OPERATIONS G5510

    Patients

    Seq Age Sex Outcome Treatment
    1 Other