BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3002 SECURE II

    MDR report key: 2223357 · Received August 17, 2011

    Report

    Report Number
    1831750-2011-08740
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 21, 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

    RESULT: CRACKED INNER HEAD LEFT SIDERAIL PANEL. THIS USER FACILITY SERVES AS THE HEALTH CARE PROVIDER FOR ONE OF THE STATE PRISONS. AS A RESULT, IT HAS BEEN REPORTED THAT PTS INTENTIONALLY DAMAGE VARIOUS DEVICE COMPONENTS WITH UNRESTRAINED APPENDAGES. ADDITIONALLY, PTS 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 THE INNER HEAD-LEFT SIDERAIL BLANK MODULE WAS BROKEN, AND THERE WAS FLUID INTRUSION LOCATED AT THE BOTTOM OF THE PANEL. IT IS UNK IF THERE WAS PT INVOLVEMENT OR ADVERSE CONSEQUENCES TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3002 SECURE II A/C POWERED HOSPITAL BED FNL STRYKER MEDICAL 3002 NA

    Patients

    Seq Age Sex Outcome Treatment
    1