BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIRIT SELECT

    MDR report key: 5095694 · Received September 22, 2015

    Report

    Report Number
    3006433555-2015-00393
    Event Type
    Malfunction
    Date Received
    September 22, 2015
    Date of Event
    August 27, 2015
    Report Date
    August 27, 2015
    Manufacturer
    STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP SUBMITTED AS THIS COMPLAINT WAS DETERMINED NOT TO BE REPORTABLE. AN OBSTRUCTION SENSOR MALFUNCTION COULD RESULT IN THE LIFT BEING STUCK, HOWEVER, IT IS NOT LIKELY TO HARM THE PATIENT. AFTER THE PATIENT WAS DISCHARGED, HOWEVER, IT WAS FOUND THAT THE BED HAD BEEN SOAKED DURING CLEANING AND ONCE THE BED DRIED IT WORKED CORRECTLY. THERE WAS NO DEFECT FOUND AND THE UNIT WAS PUT BACK INTO SERVICE. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED. THIS ISSUE IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO SERIOUS INJURY OR DEATH IF IT WAS TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS AN ISSUE WITH THE OBSTRUCTION SENSOR. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS AN ISSUE WITH THE OBSTRUCTION SENSOR. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625344 SPIRIT SELECT BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS

    Patients

    Seq Age Sex Outcome Treatment
    1