BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURE 2 MED/SURG BED

    MDR report key: 2081777 · Received April 13, 2011

    Report

    Report Number
    1831750-2011-03506
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 21, 2011
    Report Date
    March 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: POWER CORD PLUG MISSING THE GROUND PRONG. BROKEN TIMING LINK WITH SHARP EDGES. 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 HEAD LEFT TIMING LINKAGE WAS BROKEN. THE POWER CORD PLUG WAS MISSING THE GROUND PRONG, AND THE ARM COVER WAS BROKEN WITHOUT VISIBLE SHARP EDGES. 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 SECURE 2 MED/SURG BED A/C POWERED HOSPTIAL BED FNL STRYKER MEDICAL 3002 NA

    Patients

    Seq Age Sex Outcome Treatment
    1