BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIC II CRITICAL CARE BED

    MDR report key: 1890510 · Received October 29, 2010

    Report

    Report Number
    1831750-2010-03380
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 1, 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

    RESULT: CRACKED PANELS, FOOT BOARD, AND MODULE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT ALL INNER AND OUTER PANELS HAVE CRACKS IN THEM. FOOT BOARD ALSO CRACKED. NO ADVERSE CONSEQUENCES HAVE BEEN 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 CORP., MEDICAL DIV. 2030 NA

    Patients

    Seq Age Sex Outcome Treatment
    1