BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 2970686 · Received February 20, 2013

    Report

    Report Number
    3003433498-2013-00111
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Report Date
    February 19, 2013
    Manufacturer
    CARROLL HEALTHCARE
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    PER (B)(6) INVACARE CONTINUING CARE SALESMAN (B)(6) THE CUSTOMER'S HI LO MOTOR PART NUMBER 1158428 IS CRACKED AND UNDER WARRANTY BED MODEL IHCS7 SERIAL NUMBER (B)(4) / NO FOLLOW UP REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74592 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL CARROLL HEALTHCARE IHCS7

    Patients

    Seq Age Sex Outcome Treatment
    1 Other