BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURE II MED/SURG BED

    MDR report key: 3210784 · Received July 8, 2013

    Report

    Report Number
    0001831750-2013-06134
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 12, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP SUBMITTED WITH INVESTIGATION RESULTS FOR THE BRAKES NOT HOLDING. FURTHER INVESTIGATION DETERMINED THE SIDERAIL NOT WORKING WAS REPORTED IN ERROR.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED BY REPAIR WORK ORDER THAT THE BRAKES WOULD NOT HOLD. IT WAS FURTHER REPORTED THAT THE SIDERAIL WAS NOT FUNCTIONING. 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 BY REPAIR WORK ORDER THAT THE BRAKES WOULD NOT HOLD AS FOOTEND BRAKE CAM ASSEMBLY HAD A LOOSE SCREW. 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
    310645 SECURE II MED/SURG BED BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1