BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM304 M-SERIES W/ZOOM

    MDR report key: 2935463 · Received January 4, 2013

    Report

    Report Number
    1831750-2013-90048
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 5, 2012
    Report Date
    December 5, 2012
    Manufacturer
    STRYKER MEDICAL
    Product Code
    INK
    PMA / PMN Number
    K022309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CAM BRACKET. STRYKER TECHNICIAN COULD NOT REPRODUCE THE FAILURE AND FOUND THE ZOOM TO BE WORKING TO SPECIFICATION. CAM BRACKET WAS REPLACED AS A PRECAUTIONARY MEASURE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE STRETCHER STOPS WORKING PERIODICALLY. THERE WAS PT INVOLVEMENT: HOWEVER, NO ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5708 SM304 M-SERIES W/ZOOM POWERED WHEELED STRETCHER INK STRYKER MEDICAL 1025 NA

    Patients

    Seq Age Sex Outcome Treatment
    1