BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASIC CONFIGURATION MODEL 6100 BASE

    MDR report key: 2932938 · Received December 28, 2012

    Report

    Report Number
    1831750-2012-13498
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Date of Event
    December 5, 2012
    Report Date
    December 7, 2012
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATED BY CUSTOMER. MFR'S INVESTIGATION IS STILL ONGOING; IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT MAY BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE MOVING THE COT FROM THE STREET ONTO THE PAVEMENT, ONE OF THE WHEELS (BACK, RIGHT HAND SIDE) BROKE OFF THE COT. THERE WAS PATIENT INVOLVEMENT, HOWEVER, NO ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BASIC CONFIGURATION MODEL 6100 BASE STRETCHER, WHEELED FPO STRYKER MEDICAL 6100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1