BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM304 M-SERIES W/ZOOM

    MDR report key: 2841664 · Received October 24, 2012

    Report

    Report Number
    1831750-2012-11165
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    September 26, 2012
    Report Date
    September 26, 2012
    Manufacturer
    STRYKER MEDICAL
    Product Code
    INK
    PMA / PMN Number
    K022309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE HEAD END COVERS WERE BROKEN EXPOSING SHARP EDGES. THE CUSTOMER REPORTED THAT THEY DID NOT KNOW IF THERE WAS PT INVOLVEMENT OR IF THERE WERE ADVERSE CONSEQUENCES TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SM304 M-SERIES W/ZOOM POWERED WHEELED STRETCHER INK STRYKER MEDICAL 1025 NA

    Patients

    Seq Age Sex Outcome Treatment
    1