BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M-1 COT - BASE HIGH LOAD 28

    MDR report key: 3803060 · Received May 9, 2014

    Report

    Report Number
    0001831750-2014-02971
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 16, 2014
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER INVESTIGATION, THE CAUSE FOR THE COT DROP ISSUE WAS THE BASE WAS NOT LOCKED. A LIKELY CAUSE FOR THIS ISSUE MAY BE ATTRIBUTED TO USE ERROR. THE ISSUE WAS RESOLVED FOR THE CUSTOMER BY SUGGESTING IN-SERVICE TRAINING FOR THE CUSTOMER. THE UNIT WAS NOT EVALUATED BY A FIELD SERVICE REPRESENTATIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COT BASE DROPPED WHILE UNLOADING A PATIENT FROM THE AMBULANCE. IT WAS REPORTED THAT THE PATIENT RECEIVED ABRASIONS HOWEVER MEDICAL INTERVENTION AND ADVERSE CONSEQUENCES WERE NOT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COT BASE DROPPED WHILE UNLOADING A PATIENT FROM THE AMBULANCE. IT WAS REPORTED THAT THE PATIENT RECEIVED ABRASIONS HOWEVER MEDICAL INTERVENTION AND ADVERSE CONSEQUENCES WERE NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281512 M-1 COT - BASE HIGH LOAD 28 STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1