BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOGEL 2860 W/MEDSURG FRAME

    MDR report key: 3911459 · Received July 3, 2014

    Report

    Report Number
    0001831750-2014-03129
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS INITIALLY REPORTED THAT THE MATTRESS HAD FLUID INTRUSION DUE TO A DAMAGED COVER. FOLLOW-UP SUBMITTED AS FURTHER INVESTIGATION DETERMINED THE TOP COVER WAS STAINED AND THERE WAS NO EVIDENCE OF FLUID INGRESS. 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 REOCCUR.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE MATTRESS HAD FLUID INTRUSION DUE TO A DAMAGED COVER. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE MATTRESS HAD FLUID INTRUSION DUE TO A DAMAGED COVER. 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
    389313 ISOGEL 2860 W/MEDSURG FRAME MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE FNM STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1