BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIC II CRITICAL CARE BED

    MDR report key: 2873516 · Received November 15, 2012

    Report

    Report Number
    1831750-2012-12002
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 18, 2012
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION UNDERWAY; FOLLOW-UP REPORTED WILL BE SUBMITTED AS NECESSARY BASED ON INVESTIGATION RESULTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FOOTEND LIFT WAS NOT FUNCTIONING PROPERLY. NO PATIENT 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