BEUDAMED
    FDA Adverse Event Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 2213987 · Received August 17, 2011

    Report

    Report Number
    3003433498-2011-00011
    Date Received
    August 17, 2011
    Date of Event
    July 7, 2011
    Report Date
    August 11, 2011
    Manufacturer
    CARROLL HEALTHCARE
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE NURSING STAFF BELIEVES THE BED MAY HAVE CAUGHT ON A BEDSIDE CABINET OR OTHER OBSTRUCTION WHILE BEING LOWERED. THE DIMENSIONS OF THE BED PUBLISHED ON THE INVACARE WEBSITE ARE: SLEEP SURFACE: 80" SLEEP SURFACE (DECK LENGTH), OVERALL HEIGHT: 6-3/4" SLEEP SURFACE DECK TO FLOOR- LOW POSITION, BED HEIGHT: 33" SLEEP SURFACE DECK TO FLOOR - HIGH POSITION, OVERALL WIDTH: 41" OVERALL WIDTH (WITH ASSIST RAILS), BASE WIDTH: 35" OVERALL SLEEP SURFACE WIDTH (WITHOUT MATTRESS). IT IS UNKNOWN IF THE BED WAS PUSHED TOO CLOSE TO THE BEDSIDE TABLE OR TO ANOTHER OBSTRUCTION. IT IS UNKNOWN IF THERE WERE ITEMS WERE HANGING FROM THE BED THAT MAY HAVE CAUGHT ONTO THE BEDSIDE TABLE OR OTHER OBSTRUCTION. THE MEDICAL CONDITION OF THE CONSUMER IS UNKNOWN. THE CONSUMER MEDICATION REGIMEN IS UNKNOWN. THE SIZE OF THE ROOM AND THE SPACIAL CLEARANCE OF THE BED TO THE ROOM ARE UNKNOWN. NO RMA HAS BEEN ISSUED FOR THE RETURN OF THE BED FOR EVALUATION. THE NURSING HOME DID NOT INDICATE THERE WERE ANY MALFUNCTIONS WITH THE BED. THERE WERE NO INDICATIONS OF ANY INJURY TO THE CONSUMER.

    Description of Event or Problem · 1

    THE NURSING STAFF ALLEGEDLY HEARD A CRASH AND FOUND THE BED ON ITS SIDE IN THE ROOM AND THE RESIDENT ON THE FLOOR. THE MAINTENANCE STAFF BELIEVES THE BED MAY HAVE CAUGHT ON A BEDSIDE CABINET OR OTHER OBSTRUCTION WHILE BEING LOWERED. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL CARROLL HEALTHCARE ARRO LONG TERM BED

    Patients

    Seq Age Sex Outcome Treatment
    1 Other