BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800-000-000 35X84 P NYLA

    MDR report key: 3622731 · Received February 11, 2014

    Report

    Report Number
    0001831750-2014-01183
    Event Type
    Malfunction
    Date Received
    February 11, 2014
    Date of Event
    January 14, 2014
    Report Date
    January 14, 2014
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FMW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP SUBMITTED WITH UPDATED CONCLUSION. MATTRESS WAS SCRAPPED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE TOP COVER HAD FLUID INGRESS. 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 TOP COVER HAD FLUID INGRESS. 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
    91199 2800-000-000 35X84 P NYLA COVER, MATTRESS (MEDICAL PURPOSES) FMW STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1