BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIC II CRITICAL CARE BED

    MDR report key: 2231557 · Received July 22, 2011

    Report

    Report Number
    1831750-2011-07551
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 25, 2011
    Report Date
    June 26, 2011
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT WHEN THE BED WENT PAST ITS LOW LIMIT THE DRIVE SCREW BROKE THE UNIPAN COVER CAUSING POTENTIAL SHARP EDGES. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE 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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1