BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURE II MED/SURG BED

    MDR report key: 2873730 · Received November 14, 2012

    Report

    Report Number
    1831750-2012-11846
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 23, 2012
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: DAMAGED BRAKE CRANK ASSEMBLY,SPRING BRAKE RATCHET, AND LEFT AND RIGHT BRAKE RATCHET CRANK; MISSING BRAKE LATCH, BRAKE RATCHET CRANK PIN.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE BRAKES COULD NOT BE ENGAGED FROM EITHER SIDE. THE CUSTOMER REPORTED THAT THEY DID NOT KNOW IF THERE WAS PATIENT INVOLVEMENT OR IF THERE WERE ADVERSE CONSEQUENCES TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECURE II MED/SURG BED IMPLANT FNL STRYKER MEDICAL 3002 NA

    Patients

    Seq Age Sex Outcome Treatment
    1