BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM304 M-SERIES W/ZOOM

    MDR report key: 1894667 · Received November 5, 2010

    Report

    Report Number
    1831750-2010-03538
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    October 7, 2010
    Report Date
    October 7, 2010
    Manufacturer
    STRYKER CORP., MEDICAL DIVISION
    Product Code
    INK
    PMA / PMN Number
    K022309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    A STRYKER FIELD SERVICE REP SPOKE WITH THE USER FACILITY OVER THE PHONE REGARDING THIS ISSUE. THE FIELD SERVICE REP RECOMMENDED REPLACING THE LOAD CELL TO SEE IF THE PROBLEM RESOLVED. THE USER FACILITY REPORTS UPON REPLACING THE LOAD CELL, THE ZOOM SPEEDS RETURNED TO NORMAL. INVESTIGATION IS UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE ZOOM IS VERY FAST. IT IS UNK IF THERE WAS PT INVOLVEMENT OR IF THERE ARE ADVERSE CONSEQUENCES TO REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK