BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACIST

    MDR report key: 1983310 · Received February 3, 2011

    Report

    Report Number
    2134243-2011-00003
    Event Type
    Malfunction
    Date Received
    February 3, 2011
    Date of Event
    January 4, 2011
    Report Date
    February 3, 2011
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    IZQ
    PMA / PMN Number
    K063029
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT CAUSE THAT MADE THE ARM FAIL IS NOT KNOWN. THE MOST LIKELY CAUSES OF A FAILURE OF THIS KIND ARE MATERIAL WEAR/FATIGUE OVER TIME OR EXCESSIVE WEIGHT. THE RESULTS OF ACIST'S EVAL OF THE ARM ARE CONSISTENT WITH THIS TYPE OF FAILURE. THIS ARM IS AN OLDER DESIGN, AND IS BELIEVED TO HAVE BEEN INSTALLED AT THIS SITE FOR OVER FIVE YEARS. THIS REPORT IS CLOSED.

    Description of Event or Problem · 1

    NARRATIVE: THE J ARM CAME OFF OF THE ARTICULATING ARM. NO PT INVOLVEMENT. AFTER (B)(6), THE CUSTOMER FOUND THE J-ARM AND INJECTOR DANGLING FROM THE INJECTOR CABLE THAT RUNS THROUGH THE J-ARM AND ARTICULATING ARM. WORLDWIDE CASE ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACIST EMPOWERCTA INJECTOR SYSTEM - MOUNTING ARM IZQ ACIST MEDICAL SYSTEMS, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1