BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURE II MED/SURG BED

    MDR report key: 3241131 · Received July 22, 2013

    Report

    Report Number
    0001831750-2013-06546
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 27, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: MANUFACTURER¿S INVESTIGATION IS STILL ONGOING; IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    IT WAS INITIALLY REPORTED THAT THE COVER PLATE AT THE FOOT END UNDER THE GATCH LITTER WAS CATCHING ON THE SUPPORT HEADER FOR THE FOOT END LIFT MOTOR. FOLLOW-UP SUBMITTED WITH EVALUATION RESULTS WHICH DETERMINED THE FOOT COVER HAD A SHARP EDGE DUE TO BEING CAUGHT ON A BENT LIFT HEADER SCREW. IT WAS ADDITIONALLY REPORTED THAT THE HI/LOW POWER CABLE HAD EXPOSED WIRES DUE TO BEING SEVERED BY THE BENT FOOT COVER. CUSTOMER SENT PARTS TO DO REPAIRS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COVER PLATE AT THE FOOT END UNDER THE GATCH LITTER WAS CATCHING ON THE SUPPORT HEADER FOR THE FOOT END LIFT MOTOR. 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 THAT THE FOOT COVER HAD A SHARP EDGE DUE TO BEING CAUGHT ON A BENT LIFT HEADER SCREW. IT WAS ADDITIONALLY REPORTED THAT THE HI/LOW POWER CABLE HAD EXPOSED WIRES DUE TO BEING SEVERED BY THE BENT FOOT COVER. 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
    340365 SECURE II MED/SURG BED BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1