BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INX FOR INLINE

    MDR report key: 7067194 · Received November 29, 2017

    Report

    Report Number
    1523574-2017-00052
    Event Type
    Injury
    Date Received
    November 29, 2017
    Date of Event
    November 22, 2017
    Report Date
    December 28, 2017
    Manufacturer
    FERNO-WASHINGTON, INC.
    Product Code
    FPO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    EMERGENCY MEDICAL TECHNICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COT WAS EVALUATED BY AN AUTHORIZED FIELD TECHNICIAN AT THE COMPLAINANT'S LOCATION. A VISUAL AND FUNCTIONAL EVALUATION WAS CONDUCTED AND NO MALFUNCTIONS WERE NOTED AND THE COT WAS OPERATORING ACCORDING TO SPECIFICATION. AFTER REVIEW OF THE INVESTIGATION IT IS DETERMINED A MALFUNCTION OF THE COT WAS NOT THE CONTRIBUTING FACTOR TO THE INCIDENT BUT RATHER A LOOSE PAVER CATCHING THE WHEEL OF THE STRETCHER AND CREATING AN OBSTRUCTION. THE IFU FOR THE COT PROVIDES SUFFICIENT INSTRUCTIONS AND CAUTIONS FOR THE PROPER OPERATION OF THE COT AROUND POTENTIAL OBSTRUCTIONS DURING A PATIENT TRANSPORT AND PROPER PLACEMENT OF THE MEDIC CREW AND COT HEIGHT TO ENSURE A CONTROLLED AND SAFE TRANSPORT. THE COMPLAINANT DID NOT HAVE ANY ADDITIONAL INFORMATION REGARDING THE ALLEGED PATIENT INJURY AND MEDICAL INTERVENTION REQUIRED OTHER THAN WOUND CLEANING AND A BANDAID.

    Description of Event or Problem · 1

    THE COMPLAINANT ALLEGES WHILE TRANSPORTING A PATIENT, THE DEVICE CAME IN CONTACT WITH A LANDSCAPING PAVER WHILE NAVIGATING DOWN A SET OF PORCH STEPS AND THEN TIPPED OVER. THE PATIENT SUSTAINED A MINOR SKIN TEAR. THE CREW WAS ABLE TO COMPLETE THE TRANSPORT. NO FURTHER DETAILS HAVE BEEN PROVIDED.

    Description of Event or Problem · 1

    THE COMPLAINANT ALLEGES WHILE TRANSPORTING A PATIENT, THE DEVICE CAME IN CONTACT WITH A LANDSCAPING PAVER WHILE NAVIGATING DOWN A SET OF PORCH STEPS AND THEN TIPPED OVER. THE PATIENT SUSTAINED A MINOR SKIN TEAR. THE CREW WAS ABLE TO COMPLETE THE TRANSPORT. NO FURTHER DETAILS HAVE BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846188 INX FOR INLINE INX FOR INLINE FPO FERNO-WASHINGTON, INC. 0015803

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other