BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIRIT SELECT

    MDR report key: 6910233 · Received October 3, 2017

    Report

    Report Number
    3006433555-2017-00162
    Event Type
    Malfunction
    Date Received
    October 3, 2017
    Date of Event
    September 5, 2017
    Report Date
    December 7, 2017
    Manufacturer
    STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL AND FUNCTIONAL INSPECTION WAS PERFORMED BY A STRYKER FIELD SERVICE TECHNICIAN. NO COMPONENT LEVELS DEFECTS WERE IDENTIFIED. THE ALLEGED ISSUE COULD NOT BE DUPLICATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELL OUT OF BED A FEW TIMES AND THE USER DID NOT THINK THAT THE BED EXIT WAS ALARMING PROPERLY. ALTHOUGH THERE WAS PATIENT INVOLVEMENT, NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELL OUT OF BED A FEW TIMES AND THE USER DID NOT THINK THAT THE BED EXIT WAS ALARMING PROPERLY. ALTHOUGH THERE WAS PATIENT INVOLVEMENT, NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689171 SPIRIT SELECT BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS

    Patients

    Seq Age Sex Outcome Treatment
    1