BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPPORT ARM 177

    MDR report key: 4122013 · Received September 19, 2014

    Report

    Report Number
    8010042-2014-00423
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Report Date
    August 20, 2014
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    IOY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PARTS ARE AVAILABLE FOR INVESTIGATION SINCE THEY WERE SCRAPPED BY THE CUSTOMER. DUE TO THIS FACT, THE ROOT CAUSE OF THE BREAKAGE CANNOT BE ESTABLISHED. ACCORDING TO THE RECEIVED INFO THE SUPPORT ARM BROKE AT THE JOINT NEAREST TO THE BRACKET. NO INFO REGARDING MANUFACTURING DATE OF THE SUPPORT ARM HAS BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SUPPORT ARM BROKE. THERE WAS NO PT INVOLVEMENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583630 SUPPORT ARM 177 IOY MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1