BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA COMFORT, SE 4 X 30

    MDR report key: 7510841 · Received May 14, 2018

    Report

    Report Number
    0001831750-2018-00476
    Event Type
    Malfunction
    Date Received
    May 14, 2018
    Date of Event
    April 16, 2018
    Report Date
    July 3, 2018
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    IKY
    UDI-DI
    07613327298567
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE USER FACILITY HAD EXPERIENCED ISSUES WITH THE MATTRESS ALLEGEDLY SLIDING OFF THE STRETCHER DURING PATIENT TRANSFERS AND THAT THE CUSTOMER WAS NOT SATISFIED WITH THE VELCRO DESIGN. NO PRODUCT DEFECT WAS ALLEGED. THIS ISSUE WAS RESOLVED FOR THE CUSTOMER BY HAVING THE CUSTOMER TRIAL A DIFFERENT STYLE OF MATTRESS THAT WILL BETTER ALIGN WITH THEIR NEEDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MATTRESS SLIDES OFF FROM THE STRETCHER DURING PATIENT TRANSFERS FROM THE OPERATING ROOM TABLE TO THE STRETCHER. THE PATIENT WAS NOT AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MATTRESS SLIDES OFF FROM THE STRETCHER DURING PATIENT TRANSFERS FROM THE OPERATING ROOM TABLE TO THE STRETCHER. THE PATIENT WAS NOT AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352495 ULTRA COMFORT, SE 4 X 30 MATTRESS, FLOTATION THERAPY, NON-POWERED IKY STRYKER MEDICAL-KALAMAZOO 07613327298567

    Patients

    Seq Age Sex Outcome Treatment
    1