BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIRIT ONE

    MDR report key: 4879292 · Received June 30, 2015

    Report

    Report Number
    3006433555-2015-00319
    Event Type
    Malfunction
    Date Received
    June 30, 2015
    Date of Event
    November 14, 2014
    Report Date
    November 14, 2014
    Manufacturer
    STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCALE WAS INACCURATE. 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
    421449 SPIRIT ONE BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS

    Patients

    Seq Age Sex Outcome Treatment
    1