BEUDAMED
    FDA Adverse Event Injury Summary report: N

    35-XST PROFLEXX-ST RESCUE RED

    MDR report key: 11665213 · Received April 14, 2021

    Report

    Report Number
    1523574-2021-00004
    Event Type
    Injury
    Date Received
    April 14, 2021
    Date of Event
    April 4, 2021
    Report Date
    May 4, 2021
    Manufacturer
    FERNO-WASHINGTON, INC.
    Product Code
    FPO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE COT WAS EVALUATED BY AN AUTHORIZED SERVICE TECHNICIAN. A VISUAL AND FUNCTIONAL EVALUATION WAS CONDUCTED ON THE STRETCHER. THERE WERE NO ISSUES FOUND AND THE COT APPEARED TO BE FUNCTIONING AS INTENDED, WITH NO MALFUNCTIONS FOUND THAT WOULD HAVE CONTRIBUTED TO THE COT LOWERING UNEXPECTEDLY. NO FURTHER DETAILS WERE PROVIDED PERTAINING TO THE ALLEGED INJURY.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED WHILE TRANSPORTING A PATIENT INTO THE EMERGENCY ROOM, THE PATIENT SLUMPED TO THE SIDE AND THE STRETCHER ALLEGEDLY TIPPED OVER AND LANDED ON ITS SIDE. THE COMPLAINANT ALSO REPORTED THE PATIENT SUSTAINED AN INJURY; HOWEVER DID NOT PROVIDE ANY DETAILS AND NOTED THE MEDICAL TREATMENT AS "UNKNOWN".

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED WHILE TRANSPORTING A PATIENT INTO THE EMERGENCY ROOM, THE PATIENT SLUMPED TO THE SIDE AND THE STRETCHER ALLEGEDLY TIPPED OVER AND LANDED ON ITS SIDE. THE COMPLAINANT ALSO REPORTED THE PATIENT SUSTAINED AN INJURY; HOWEVER DID NOT PROVIDE ANY DETAILS AND NOTED THE MEDICAL TREATMENT AS "UNKNOWN".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564425 35-XST PROFLEXX-ST RESCUE RED 35-XST PROFLEXX-ST RESCUE RED FPO FERNO-WASHINGTON, INC. 0015790

    Patients

    Seq Age Sex Outcome Treatment
    1 Other