BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ-PRO R4 AMBUL COT OBS(5/08)

    MDR report key: 3053009 · Received April 11, 2013

    Report

    Report Number
    0001831750-2013-03177
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER COMPLETION OF THE INVESTIGATION, THE COT HAD EVENT COULD NOT BE DUPLICATED AS REPORTED BY THE STRYKER FIELD SERVICE REP. A REVIEW OF PREVIOUS SIMILAR COMPLAINTS IDENTIFIED THAT THE MOST LIKELY CAUSE AS TO WHY THE COT HAD DROPPED MAY HAVE BEEN DUE TO OPERATOR ERROR. THE MANUAL INDICATES THAT THE OPERATORS SHOULD "ALWAYS VERIFY THE BASE FRAME IS SECURELY LOCKED INTO POSITION BEFORE RELEASE YOUR GRIP ON THE LITTER FRAME" AND THAT "AN UNLOCKED BASE FRAME WILL NOT SUPPORT THE COT AND INJURY TO THE PATIENT OR OPERATOR COULD RESULT." THE SERVICE TECHNICIAN REPORTED THAT HE DID SPEAK WITH THE CUSTOMER REGARDING PROPER OPERATIONS AND THAT THEY WOULD FOLLOW UP WITH THE EMTS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT AN EMPLOYEE WAS GETTING READY TO PUT A PATIENT IN THE AMBULANCE AND THE STRETCHER DROPPED WITH THE PATIENT ON IT. ALLEGEDLY THE EMPLOYEE TRIED TO STOP THE FALL AND HIS FINGER WAS CAUGHT IN THE STRETCHER. IT WAS REPORTED THAT THE EMPLOYEE'S FINGER HAD TO BE SPLINTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT AN EMPLOYEE WAS GETTING READY TO PUT A PATIENT IN THE AMBULANCE AND THE STRETCHER DROPPED WITH THE PATIENT ON IT. ALLEGEDLY THE EMPLOYEE TRIED TO DROP THE FALL AND HIS FINGER WAS CAUGHT IN THE STRETCHER. IT WAS REPORTED THAT THE EMPLOYEE'S FINGER HAD TO BE SPLINTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156563 EZ-PRO R4 AMBUL COT OBS(5/08) STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1