BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM304 M-SERIES W/ZOOM

    MDR report key: 2935523 · Received January 4, 2013

    Report

    Report Number
    1831750-2013-90044
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    November 28, 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
    IA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SCALE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE SCALE WOULD NOT ZERO AND GAVE INACCURATE READINGS. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5627 SM304 M-SERIES W/ZOOM POWERED WHEELED STRETCHER INK STRYKER MEDICAL 1025 NA

    Patients

    Seq Age Sex Outcome Treatment
    1