BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIRIT SELECT

    MDR report key: 5061817 · Received September 8, 2015

    Report

    Report Number
    3006433555-2015-00378
    Event Type
    Malfunction
    Date Received
    September 8, 2015
    Date of Event
    July 12, 2015
    Report Date
    August 13, 2015
    Manufacturer
    STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS (MDR)
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT WAS EVALUATED BY THE DISTRIBUTOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THE BED EXIT WAS NOT FUNCTIONING PROPERLY DUE TO THE SCALE NEEDING TO BE ZEROED. 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
    591643 SPIRIT SELECT BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS (MDR)

    Patients

    Seq Age Sex Outcome Treatment
    1