BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM304 M-SERIES W/ZOOM

    MDR report key: 3021694 · Received March 26, 2013

    Report

    Report Number
    0001831750-2013-02515
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    INK
    PMA / PMN Number
    K022309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE PREVIOUS EMDR INITIAL REPORT, THE PMA/510(K)# WAS NOT INCLUDED. THE PMA/510(K)# IS INCLUDED IN THIS SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE ZOOM SURGES WHILE IN STEER DUE TO THE DRIVE MOTOR SHIFTING LATERALLY AND WAS RUBBING ON THE FRAME(CSI BOX ASSEMBLY). NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE ZOOM SURGES WHILE IN STEER DUE TO THE DRIVE MOTOR SHIFTING LATERALLY AND WAS RUBBING ON THE FRAME(CSI BOX ASSEMBLY). NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124683 SM304 M-SERIES W/ZOOM STRETCHER, WHEELED, POWERED INK STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1