BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIRIT SELECT

    MDR report key: 4879349 · Received June 30, 2015

    Report

    Report Number
    3006433555-2015-00321
    Event Type
    Malfunction
    Date Received
    June 30, 2015
    Date of Event
    November 25, 2011
    Report Date
    January 2, 2015
    Manufacturer
    STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CHG HOSPITAL BEDS, INC. WAS ACQUIRED BY STRYKER ON JAN. 2, 2015.  THIS MEDWATCH IS BEING SUBMITTED LATE BECAUSE IT WAS IDENTIFIED DURING THE  INTEGRATION AND REMEDIATION ACTIVITIES INITIATED BY STRYKER MEDICAL IN CONJUNCTION WITH THIS ACQUISITION.   DISTRIBUTOR HELPED ACCOUNT TROUBLESHOOT OVER PHONE

    Description of Event or Problem · 1

    IT WAS REPORTED THE BED EXIT ALARM WAS NOT OPERATING PROPERLY. THE NURSE WAS INSTRUCTED TO RESEAT THE FOOTBOARD, AND FUNCTIONALITY WAS RESTORED. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421321 SPIRIT SELECT BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS

    Patients

    Seq Age Sex Outcome Treatment
    1