BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIRIT SELECT

    MDR report key: 6096300 · Received November 11, 2016

    Report

    Report Number
    3006433555-2016-00250
    Event Type
    Malfunction
    Date Received
    November 11, 2016
    Date of Event
    October 14, 2016
    Report Date
    April 5, 2018
    Manufacturer
    STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED "MANUFACTURING SITE FOR DEVICES".

    Additional Manufacturer Narrative · 1

    THERE WAS NO DEFECT ALLEGED WITH THIS PRODUCT, AND THE ISSUE WAS RESOLVED FOR THE CUSTOMER BY CONFIRMING THAT NOTHING FURTHER WAS NEEDED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A SHARP METAL EDGE ON THE RETAINING RINGS OF THE BED'S FOOTBOARD, AND A NURSE CUT HERSELF ON ONE. THE CUT WAS NOT SEVERE ENOUGH TO REQUIRE STITCHES, AND SHE DID NOT REQUIRE ANY ADDITIONAL MEDICAL INTERVENTION. NO FURTHER INFORMATION REGARDING THE EVENT WAS REPORTED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A SHARP METAL EDGE ON THE RETAINING RINGS OF THE BED'S FOOTBOARD, AND A NURSE CUT HERSELF ON ONE. THE CUT WAS NOT SEVERE ENOUGH TO REQUIRE STITCHES, AND SHE DID NOT REQUIRE ANY ADDITIONAL MEDICAL INTERVENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A SHARP METAL EDGE ON THE RETAINING RINGS OF THE BED'S FOOTBOARD, AND A NURSE CUT HERSELF ON ONE. THE CUT WAS NOT SEVERE ENOUGH TO REQUIRE STITCHES, AND SHE DID NOT REQUIRE ANY ADDITIONAL MEDICAL INTERVENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A SHARP METAL EDGE ON THE RETAINING RINGS OF THE BED'S FOOTBOARD, AND A NURSE CUT HERSELF ON ONE. THE CUT WAS NOT SEVERE ENOUGH TO REQUIRE STITCHES, AND SHE DID NOT REQUIRE ANY ADDITIONAL MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747866 SPIRIT SELECT BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS

    Patients

    Seq Age Sex Outcome Treatment
    1