BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURE 2 MED/SURGBED

    MDR report key: 2033156 · Received February 28, 2011

    Report

    Report Number
    1831750-2011-01955
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    February 5, 2011
    Report Date
    February 5, 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: COMMUNICATION CORD. THE 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 POWER CORD WAS MISSING THE GROUND PRONG. IT WAS FURTHER REPORTED THE COM CORD HAD BENT AND MISSING PINS. IT IS UNK IF THERE WAS PT INVOLVEMENT OR IF THERE ARE ADVERSE CONSEQUENCES TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECURE 2 MED/SURGBED A/C POWERED HOSPITAL BED FNL STRYKER MEDICAL 3002 NA

    Patients

    Seq Age Sex Outcome Treatment
    1