BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS BED 9153650455

    MDR report key: 4817471 · Received June 4, 2015

    Report

    Report Number
    3003433498-2015-00075
    Event Type
    Malfunction
    Date Received
    June 4, 2015
    Date of Event
    November 3, 2014
    Report Date
    May 7, 2015
    Manufacturer
    INVACARE CONTINUING CARE
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP WILL BE SENT IF THE PRODUCT OR ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    AS A RESULT OF PIN HOLDING POWER HEAD ACTUATOR MECHANISM BREAKING OR POPPING OUT, END USER ALLEGEDLY DROPPED INTO A HORIZONTAL POSITION WHILE RAISING HEAD OF BED. HE APPARENTLY HAD SOME INITIAL PAIN AND SAW DOCTOR. THERE WAS NO REHAB OR MEDICATION PRESCRIBED. END USERS ISSUE AT THIS POINT IS NOISE THAT BED MAKES WHEN HE INITIATES RAISING HEAD OF BED. HE ALSO CLAIMS THAT THERE HAS BEEN OIL AND METAL SHAVINGS LEFT ON CARPET UNDER BED. DEALER TECHNICIAN REPLACED ORIGINAL PIN FOR ACTUATOR WITH A STRONGER MORE ROBUST BOLT AND ALSO REPLACED HEADBOARD GUIDE WHEELS WITH SUPERIOR URETHANE ONES TO HELP ELIMINATE NOISE. DEALER TECHNICIAN SAYS HE CANNOT FID SOURCE OF LEAKING OIL OR METAL SHAVINGS. DEALER TECHNICIAN CLAIMS THAT REASON BED IS MAKING A NOISE, IS A RESULT OF END USER'S WEIGHT BEING CLOSE TO OR OVER THE MAXIMUM WEIGHT CAPACITY OF BED WHEN ADDING WEIGHT OF THE SIDE RAILS AND MATTRESS. DEALER TECHNICIAN ALSO CLAIMS THAT BED MAKES NO NOISE WHEN LIFTING HIS OWN PERSONAL WEIGHT. ((B)(6))

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361519 CS BED 9153650455 BED, AC-POWERED ADJUSTABLE HOSPITAL FNL INVACARE CONTINUING CARE HCBED

    Patients

    Seq Age Sex Outcome Treatment
    1 61 Other