BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3002 SECURE II

    MDR report key: 2221708 · Received August 15, 2011

    Report

    Report Number
    1831750-2011-08600
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 12, 2011
    Report Date
    August 12, 2011
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: DAMAGED HEAD RIGHT SIDERAIL CABLE WITH EXPOSED WIRES. MDR IS BEING ISSUED BECAUSE FURTHER INVESTIGATION CONCLUDED THAT THERE IS A POTENTIAL RISK TO SAFETY ASSOCIATED WITH THE HEAD RIGHT SIDERAIL CABLE EXPOSED WIRES POSSIBLY SHORTING OUT THE CPU DUE TO DAMAGED TIGHT ZIP TIES OR A LOSS OF SIDERAIL CABLE RETENTION, BECAUSE IT WOULD HINDER CRITICAL FUNCTIONS, SUCH AS BED EXIT, USED TO AID STAFF IN THE DETECTION OF PTS MOVING OUT OF BED. RC: DAMAGED HEAD RIGHT SIDERAIL CABLE WITH EXPOSED WIRES.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE HEAD RIGHT SIDERAIL CABLE WAS DAMAGED WITH BARE WIRES EXPOSED. 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