BEUDAMED
    FDA Adverse Event Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 2562974 · Received May 8, 2012

    Report

    Report Number
    1531186-2012-00222
    Date Received
    May 8, 2012
    Date of Event
    February 20, 2012
    Report Date
    May 7, 2012
    Manufacturer
    HL CORP. (SHENZHEN)
    Product Code
    FNL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONSUMER IS A FEMALE WHOSE AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMER'S MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMER'S TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. THE DEALER STATED THAT THE CONSUMER WAS ALMOST OUT OF HER BED WHEN THE RAIL BROKE AT THE WELD. THE CONSUMER FELL AND ALLEGEDLY BROKE HER FOOT. THE BED RAILS, MODEL #6630, DATE CODE (B)(4), ARE ATTACHED TO AN INVACARE 5410IVC FULL ELECTRIC BED, SERIAL #(B)(4). THE CONSUMER'S WEIGHT AND TECHNIQUE OF GETTING IN AND OUT OF BED ARE UNKNOWN. THE OWNER'S MANUAL STATES WARNINGS, "THESE BED RAILS ARE INTENDED TO PREVENT AN INDIVIDUAL FROM INADVERTENTLY ROLLING OUT OF BED. DO NOT USE FOR RESTRAINT PURPOSES. ALTHOUGH BED RAILS ARE NOT RATED TO ANY SPECIFIC WEIGHT LIMITATION, THE BED RAILS MAY BECOME DEFORMED OR BROKEN IF EXCESSIVE SIDE PRESSURE IS EXERTED ON THE BED RAILS. THIS BED RAIL IS NOT AN ASSIST RAIL FOR GETTING INTO OR OUT OF BED. DO NOT USE THE BED RAILS AS PUSH HANDLES WHEN MOVING THE BED". THE CONSUMER IS STILL USING THE BED AND MATTRESS. THE DEALER HAS PROVIDED THE CONSUMER WITH A NEW SET OF 6630 BED RAILS. RMA (B)(4) HAS BEEN INITIATED FOR THIS ISSUE AND THE DAMAGED BED RAILS ARE TO BE RETURNED TO INVACARE FOR AN INSPECTION AND EVALUATION.

    Description of Event or Problem · 1

    CUSTOMER ALLEGED BED RAILS BROKE AT THE WELD. SERIOUS INJURY ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL HL CORP. (SHENZHEN) 6630

    Patients

    Seq Age Sex Outcome Treatment
    1 Other