BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIC II CRITICAL CARE BED

    MDR report key: 1925716 · Received November 23, 2010

    Report

    Report Number
    1831750-2010-04137
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    October 27, 2010
    Report Date
    October 27, 2010
    Manufacturer
    STRYKER CORP., MEDICAL DIV.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: FOOTBOARD MODULES AND SIDERAIL PANELS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SVC REPORT THAT ALL THE INNER AND OUTER SIDERAIL PANELS ARE CRACKED. IT WAS FURTHER REPORTED THAT FOOTBOARD MODULES NEEDED TO BE REPLACED. THERE WAS PT INVOLVEMENT, HOWEVER NO ADVERSE CONSEQUENCES ARE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIC II CRITICAL CARE BED AC POWERED HOSPITAL BED FNL STRYKER CORP., MEDICAL DIV. 2030000000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1