BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 2746339 · Received September 15, 2012

    Report

    Report Number
    3003433498-2012-00035
    Event Type
    Malfunction
    Date Received
    September 15, 2012
    Report Date
    September 14, 2012
    Manufacturer
    CARROLL HEALTHCARE
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL CS3, SERIAL NUMBER/DATE (B)(4). THE OWNER'S MANUAL PART NUMBER 1153410, WAS ISSUED WITH THIS DEVICE. THE OWNER'S MANUAL IS ALSO FOUND ON-LINE AT INVACARE.COM. THE FACILITY, (B)(6) CALLED STATING THAT TWO WHEELS FOR THE CS3 CARROLL HEALTHCARE BED ARE ALLEGEDLY CRACKED, OUT OF THE BOX. REPLACEMENT WHEELS HAVE BEEN SENT. THIS BED WAS NOT ASSIGNED TO A PARTICULAR RESIDENT. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    ON (B)(6) - THE FACILITY STAFF INDICATED THAT THE CS3 BED HAD TWO CRACKED WHEELS. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL CARROLL HEALTHCARE CS3

    Patients

    Seq Age Sex Outcome Treatment
    1 Other