BEUDAMED
    FDA Adverse Event Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 4191858 · Received October 22, 2014

    Report

    Report Number
    1531186-2014-04997
    Date Received
    October 22, 2014
    Report Date
    October 20, 2014
    Manufacturer
    LAND AMERICA HEALTH & FITNESS
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FACILITY REPORTED THAT THE END USER STATED, ANY TIME SHE TOUCHES A METAL PART OF THE BAR600IVC BARIATRIC BED, SHE IS GETTING SHOCKED. NO ALLEGED INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671513 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL LAND AMERICA HEALTH & FITNESS BAR600IVC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other