BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDIAN

    MDR report key: 965050 · Received July 6, 2006

    Report

    Report Number
    3003781173-2006-00005
    Event Type
    Malfunction
    Date Received
    July 6, 2006
    Date of Event
    June 20, 2006
    Report Date
    July 3, 2006
    Manufacturer
    ZHONGSHAN A&E MACHINERY INDUSTRY CO., LTD.
    Product Code
    ITJ
    Removal / Correction Number
    3003781173-7/03/06-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THIS EVENT WAS REPORTED TO SUNRISE CUSTOMER SERVICE VIA PHONE CALL FROM THE FACILITY IN 2006. SUNRISE MEDICAL SUBSEQUENTLY PROVIDED MDR #1034630-2006-0027 TO US AGENT FOR ZHONGSHAN A&E MACHINERY INDUSTRY CO., LTD., ABOUT ONE WEEK LATER. REPORTER CLAIMS THE WHEEL HAS BROKEN. THE UNIT HAS NOT BEEN REC'D FOR EVAL BY SUNRISE MEDICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUARDIAN 8 HOLE FOOTPIECE SET 5" WHEEL ITJ ZHONGSHAN A&E MACHINERY INDUSTRY CO., LTD. 07722-8 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN