BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SARA 3000

    MDR report key: 2683188 · Received July 31, 2012

    Report

    Report Number
    3004468271-2012-00032
    Event Type
    Malfunction
    Date Received
    July 31, 2012
    Report Date
    July 6, 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

    (B)(4) BY ARJOHUNTLEIGH, INC. ON BEHALF OF THE MFR MEDIBO MEDICAL (B)(4). THE EVAL OF THE DEVICE TO DATE HAS BEEN CARRIED OUT BY A REP OF THE MFR'S SALES AND SERVICE UNIT SUBSIDIARY DIVISION, NOT A DIRECT EMPLOYEE OF THE MFR. ADDITIONAL INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    ACCORDING TO THE MFR REP: SARA 3000 SCALE - READING 5KG LIGHTER. CUSTOMER PURCHASE DATE: (B)(6) 2011. SCALE IS MEASURING INCORRECTLY AND MAST BOLTS ARE LOOSE. REPLACED BATTERIES (4XAA) IN SCALE UNIT AND FITTED BOLTS WITH LOCKTITE. TESTED SCALE WITH WEIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SARA 3000 ACTIVE FLOOR LIFTS FSA MEDIBO MEDICAL PRODUCTS NV HEA1002-AU

    Patients

    Seq Age Sex Outcome Treatment
    1