BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MX PRO COT LINE

    MDR report key: 2830442 · Received October 10, 2012

    Report

    Report Number
    1831750-2012-10652
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 12, 2012
    Report Date
    September 12, 2012
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    HEIGHT ADJUSTMENT RACKS. MANUFACTURERS INVESTIGATION IS STILL ONGOING; IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT MAY BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE HEIGHT ADJUSTMENT WERE BENT. THE CUSTOMER REPORTED THAT THEY DID NOT KNOW IF THERE WAS ANY PATIENT INVOLVEMENT OR IF THERE WERE ADVERSE CONSEQUENCES TO REPORT. MANUFACTURERS INVESTIGATION IS STILL ONGOING; IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT MAY BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MX PRO COT LINE STRETCHER, COT FPO STRYKER MEDICAL UNKNOWN NA

    Patients

    Seq Age Sex Outcome Treatment
    1