BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM304 M-SERIES W/ZOMM

    MDR report key: 2904473 · Received November 30, 2012

    Report

    Report Number
    1831750-2012-12458
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 2, 2012
    Manufacturer
    STRYKER MEDICAL
    Product Code
    INK
    PMA / PMN Number
    K022309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE SIDERAIL WOULD NOT LATCH IN THE UPRIGHT POSITION. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1