BEUDAMED
    FDA Adverse Event Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 2575584 · Received May 16, 2012

    Report

    Report Number
    1531186-2012-00260
    Date Received
    May 16, 2012
    Report Date
    May 14, 2012
    Manufacturer
    HL CORP. (SHENZHEN)
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEALER STATED THAT A BOLT ON THE LOWER LEFT SIDE BED RAIL BROKE, RENDERING THE BED RAIL NONFUNCTIONAL. THE CONSUMER'S AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMER'S TECHNIQUE USING THE BED RAILS IS UNKNOWN. PAGE 1 OF THE OWNER'S MANUAL STATES A WARNING, "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. THESE BED RAILS ARE INTENDED TO PREVENT AN INDIVIDUAL FROM INADVERTENTLY ROLLING OUT OF BED. DO NOT USE FOR RESTRAINT PURPOSES". IT IS UNKNOWN IF THE 6630 BED RAILS ARE INSTALLED ON AN INVACARE BED. PAGE 1 OF THE OWNER'S MANUAL ALSO STATES A WARNING, "INVACARE PRODUCTS ARE SPECIFICALLY DESIGNED AND MANUFACTURED FOR USE IN CONJUNCTION WITH INVACARE ACCESSORIES. ACCESSORIES DESIGNED BY OTHER MANUFACTURERS HAVE NOT BEEN TESTED BY INVACARE AND ARE NOT RECOMMENDED FOR USE WITH INVACARE PRODUCTS". NO RMA HAS BEEN ISSUED AT THIS TIME FOR THE RETURN OF THE BED RAILS. NO INJURY OR MEDICAL INTERVENTION IS ALLEGED.

    Description of Event or Problem · 1

    CUSTOMER ALLEGED A LOOSE/BROKEN BOLT ON THE RAIL. NO 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