BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S3 EX - 3005

    MDR report key: 3022878 · Received March 27, 2013

    Report

    Report Number
    0001831750-2013-02573
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 4, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP SUBMITTED AS IT WAS DETERMINED THIS WAS JUST TRAINING TO EDUCATE CUSTOMER STAFF IN SCALE USE, NO FAILURE OF PRODUCT WAS ALLEGED OR REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE SCALE READING WAS FLUCTUATING. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE SCALE READING WAS FLUCTUATING. HOWEVER, THERE WAS NO MALFUNCTION WITH THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125380 S3 EX - 3005 BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1