BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURE II MED/SURG BED

    MDR report key: 3031512 · Received April 2, 2013

    Report

    Report Number
    0001831750-2013-02833
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP BEING SUBMITTED AS THE ORIGINAL REPORT HAD THE HEADEND BUMPERS MISSING WITH EXPOSED ELECTRICAL WIRES. THE INVESTIGATION DETERMINED THAT THERE WERE NO EXPOSED ELECTRICAL WIRES. THE EXECUTIVE SUMMARY AND METHOD, RESULTS AND CONCLUSION HAVE BEEN UPDATED. THE ISSUE OF THE HEADEND BUMBERS MISSING IS ADDRESSED IN THE FOLLOWING NON-REPORTABLE RATIONALE: IT WAS REPORTED THAT THE HEAD END BUMPERS WERE MISSING. THIS WILL RESULT IN CAREGIVER ANNOYANCE AS THE BUMPERS DO NOT AFFECT CRITICAL BED FUNCTIONS AND NO SHARP EDGES WERE REPORTED. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCES OR CLINICALLY RELEVANT DELAYS IN TREATMENT WERE REPORTED. THIS ISSUE IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO SERIOUS INJURY OR DEATH IF IT WERE TO RECUR. THEREFORE, THIS EVENT IS NOT REPORTABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE MOTION INTERRUPT PAN WAS BROKEN AND THE BUMPER ROLLERS WERE MISSING WITH EXPOSED ELECTRICAL WIRES. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE MOTION INTERRUPT PAN WAS BROKEN. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135233 SECURE II MED/SURG BED BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1