BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURE II MED/SURG BED

    MDR report key: 2924709 · Received January 22, 2013

    Report

    Report Number
    0001831750-2013-00237
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 2, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: FOWLER CLUTCH.

    Additional Manufacturer Narrative · 1

    UPON FURTHER INVESTIGATION, IT WAS DETERMINED THAT A DUPLICATE PR WAS ENTERED FOR THIS PRODUCT. INTERNALLY (B)(4) AND EXTERNALLY MW # (B)(4) ADDRESS THE INVESTIGATION AND REGULATORY ASSESSMENTS FOR THIS PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE FOWLER DRIFTED DOWN.

    Description of Event or Problem · 1

    UPON FURTHER INVESTIGATION, IT WAS DETERMINED THAT A DUPLICATE PR WAS ENTERED FOR THIS PRODUCT. INTERNALLY (B)(4) AND EXTERNALLY MW # (B)(4) ADDRESS THE INVESTIGATION AND REGULATORY ASSESSMENTS FOR THIS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29738 SECURE II MED/SURG BED BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1