BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURE II MED/SURG BED

    MDR report key: 2220387 · Received August 15, 2011

    Report

    Report Number
    2220387
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 15, 2011
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    DURING ROUTINE SERVICE, BRAKES FAILED THE LATERAL PULL TEST. CASTERS ROLLED AT 22 LBS VERSUS A SPECIFICATION OF 50LBS.======================MANUFACTURER RESPONSE FOR MED/SURG BED, STRYKER (PER SITE REPORTER)======================SERVICE TECH WILL BE SENT TO REPLACE BRAKE KIT PARTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *