BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIC II CRITICAL CARE BED

    MDR report key: 2760707 · Received September 19, 2012

    Report

    Report Number
    1831750-2012-09930
    Event Type
    Malfunction
    Date Received
    September 19, 2012
    Date of Event
    August 23, 2012
    Report Date
    August 23, 2012
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: FOWLER BUSING WAS WORN. CPR CABLES WERE OUT OF PLACE.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A SERVICE REPORT THAT THE FOWLER AND THE CPR CABLE WERE BROKEN. THE CUSTOMER REPORTED THAT THEY DID NOT KNOW IF THERE WAS PT INVOLVEMENT; HOWEVER, NO 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