BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURE II MED/SURG BED

    MDR report key: 1973844 · Received December 28, 2010

    Report

    Report Number
    1831750-2010-05216
    Event Type
    Malfunction
    Date Received
    December 28, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 2, 2010
    Manufacturer
    STRYKER CORP., MEDICAL DIV.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INCOMPATIBLE COMPONENTS, IT WAS FOUND THAT THE FOOTBOARD WAS NOT CONFIGURED FOR THE BED. IT IS LIKELY THAT THE FOOTBOARD WAS SWAPPED WITH A DIFFERENT CONFIGURATION OF PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT, THE PRODUCT HAD VARIOUS ISSUES. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT OR IF THERE ARE ADVERSE CONSEQUENCES TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECURE II MED/SURG BED AC POWERED HOSPITAL BED FNL STRYKER CORP., MEDICAL DIV. 3002 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK