BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIC II CRITICAL CARE BED

    MDR report key: 2050661 · Received March 14, 2011

    Report

    Report Number
    1831750-2011-02467
    Event Type
    Malfunction
    Date Received
    March 14, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 22, 2011
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY SERVES AS THE HEALTH CARE PROVIDER FOR ONE OF THE STATE PRISONS. AS A RESULT, IT HAS BEEN REPORTED THAT PATIENTS INTENTIONALLY DAMAGE VARIOUS DEVICE COMPONENTS WITH UNRESTRAINED APPENDAGES. ADDITIONALLY, PATIENTS ARE REGULARLY RESTRAINED IN MANNERS THAT CONFLICT WITH THE DEVICE'S INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THERE WAS A BROKEN HEAD RAIL ON THE RIGHT SIDERAIL. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT OR IF THERE ARE ADVERSE CONSEQUENCES TO REPORT.

    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 EPIC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK