BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIC II CRITICAL CARE BED

    MDR report key: 2111358 · Received May 18, 2011

    Report

    Report Number
    1831750-2011-04857
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 10, 2011
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: BRAKE PLATE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE BRAKES WERE NOT HOLDING. NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIC II CRITICAL CARE BED A/C POWERED HOSPITAL BED FNL STRYKER MEDICAL 2030 EPIC+ NA

    Patients

    Seq Age Sex Outcome Treatment
    1