BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SARA 3000

    MDR report key: 2676164 · Received July 25, 2012

    Report

    Report Number
    3004468271-2012-00027
    Event Type
    Malfunction
    Date Received
    July 25, 2012
    Date of Event
    June 25, 2012
    Report Date
    June 25, 2012
    Manufacturer
    MEDIBO MEDICAL PRODUCTS NV
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH, INC ON BEHALF OF THE MANUFACTURER MEDIBO MEDICAL PRODUCTS (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO CUSTOMER DESCRIPTION DEVICE HAS A BURNING SMELL WHILE IN USE AND HAS STOPPED WORKING. THE ARJOHUNTLEIGH SERVICE TECHNICIAN FOUND THAT PRINTED CIRCUIT BOARD WAS BLOWN. PCB WAS REPLACED. UNIT IS SERVICED BY ARJOHUNTLEIGH AND IS IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SARA 3000 ACTIVE FLOOR LIFTS FSA MEDIBO MEDICAL PRODUCTS NV HEA0002-AU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other