BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM104 MSERIES W5TH

    MDR report key: 2466916 · Received February 14, 2012

    Report

    Report Number
    1831750-2012-01298
    Event Type
    Malfunction
    Date Received
    February 14, 2012
    Date of Event
    January 17, 2012
    Report Date
    January 17, 2012
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SIDERAIL ASSY PART# 0785-011-040 IS ON ORDER AND WILL BE INSTALLED ONCE ITS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SVC REPORT THAT THE SIDERAIL COULD NOT BE LATCHED AND SIDERAIL WELD WAS BROKEN, EXPOSED SHARP EDGES. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SM104 MSERIES W5TH HOSPITAL WHEELED STRETCHER FPO STRYKER MEDICAL 1005 NA

    Patients

    Seq Age Sex Outcome Treatment
    1