BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM304 M-SERIES W/ZOOM

    MDR report key: 1974697 · Received December 29, 2010

    Report

    Report Number
    1831750-2010-05328
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    December 6, 2010
    Report Date
    December 6, 2010
    Manufacturer
    STRYKER CORP., MEDICAL DIV.
    Product Code
    INK
    PMA / PMN Number
    K022309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE ZOOM DRIVE SURGES WHEN USING IT. NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK