BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM304 M-SERIES W/ZOOM

    MDR report key: 2891296 · Received November 29, 2012

    Report

    Report Number
    1831750-2012-12393
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 5, 2012
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FPO
    PMA / PMN Number
    K022309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THERE WERE EXPOSED SHARP EDGES DUE TO DAMAGED COVERS. THE CUSTOMER REPORTED THAT THEY DID NOT KNOW IF THERE WAS PT INVOLVEMENT; HOWEVER, NO ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1