BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM104 MSERIES W5TH WHL

    MDR report key: 2073035 · Received April 21, 2011

    Report

    Report Number
    1831750-2011-03888
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 24, 2011
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    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 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 LEFT LOCKING SPINDLE WAS BROKEN OUT OF THE LITTER FRAME AND THE SIDERAIL COULD NOT BE LATCHED UP. IT IS UNK IF THERE WAS PT INVOLVEMENT OR IF THERE WERE ADVERSE CONSEQUENCES TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SM104 MSERIES W5TH WHL HOSPITAL WHEELED STRETCHER FPO STRYKER MEDICAL 1005 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK