BEUDAMED
    FDA Adverse Event Death Summary report: N

    35X PROFLEXX

    MDR report key: 7804869 · Received August 22, 2018

    Report

    Report Number
    1523574-2018-00029
    Event Type
    Death
    Date Received
    August 22, 2018
    Date of Event
    July 26, 2018
    Report Date
    October 5, 2018
    Manufacturer
    FERNO-WASHINGTON, INC.
    Product Code
    FPO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER ADDITIONAL COMMUNICATION WITH AN EMS REPRESENTATIVE IT WAS STATED THE INITIAL REPORT OF THE COT REMAINING IN THE FASTENER WAS INCORRECT. THE COT WAS FOUND DISENGAGED FROM THE FASTENER AFTER THE ACCIDENT. THE EMS REPRESENTATIVE FURTHER STATED THE PATIENT WAS PROPERLY RESTRAINED AND THE COT WAS SECURED PRIOR TO TRANSPORT. REVIEW OF PICTURES AND MEDIA ARTICLES CONFIRM THE SEVERE NATURE OF THIS MOTOR VEHICLE ACCIDENT. THIS INVESTIGATION REMAINS OPEN.

    Additional Manufacturer Narrative · 1

    A REVIEW OF PHOTOGRAPHS INDICATE THE COT AND FASTENER WERE SUBJECTED TO EXTREME OUTSIDE FORCES. TO DATE NEITHER THE COT OR FASTENER HAVE BEEN MADE AVAILABLE FOR EVALUATION. THE ALLEGED DISENGAGEMENT OF THE COT FROM THE FASTENER IS ATTRIBUTED TO THE HIGH VELOCITY, SEVERE IMPACT AND ROLLOVER OF THE AMBULANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED AN AMBULANCE WAS INVOLVED IN AN MVA WHICH RESULTED IN A PATIENT DEATH. THE AMBULANCE WAS GOING APPROXIMATELY 60 MPH AT THE TIME OF IMPACT AND ROLLED COMING TO REST ON ITS TOP. THE COT WAS REPORTED TO HAVE STAYED LOCKED IN THE FASTENER; HOWEVER, THE PATIENT CAME LOOSE FROM THE RESTRAINTS. IT WAS STATED THE PATIENT'S LARGE BODY SIZE DID MAKE IT DIFFICULT TO RESTRAIN THE PATIENT TO THE COT. IT WAS ALSO STATED THE PATIENT'S CONDITION PRIOR TO THE MVA WAS LISTED AS CRITICAL. THERE HAVE BEEN NO ALLEGATIONS OF PRODUCT MALFUNCTION OR FAILURE. THE EMS COMPANY HAS BEEN CONTACTED TO CONFIRM THE REPORT, SEEK ADDITIONAL INFORMATION AND OBTAIN THE SERIAL NUMBER OF THE COT INVOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED AN AMBULANCE WAS INVOLVED IN AN MVA WHICH RESULTED IN A PATIENT DEATH. THE AMBULANCE WAS GOING APPROXIMATELY 60 MPH AT THE TIME OF IMPACT AND ROLLED COMING TO REST ON ITS TOP. THE COT WAS REPORTED TO HAVE STAYED LOCKED IN THE FASTENER; HOWEVER, THE PATIENT CAME LOOSE FROM THE RESTRAINTS. IT WAS STATED THE PATIENT'S LARGE BODY SIZE DID MAKE IT DIFFICULT TO RESTRAIN THE PATIENT TO THE COT. IT WAS ALSO STATED THE PATIENT'S CONDITION PRIOR TO THE MVA WAS LISTED AS CRITICAL. THERE HAVE BEEN NO ALLEGATIONS OF PRODUCT MALFUNCTION OR FAILURE. THE EMS COMPANY HAS BEEN CONTACTED TO CONFIRM THE REPORT, SEEK ADDITIONAL INFORMATION AND OBTAIN THE SERIAL NUMBER OF THE COT INVOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED AN AMBULANCE WAS INVOLVED IN AN MVA WHICH RESULTED IN A PATIENT DEATH. THE AMBULANCE WAS GOING APPROXIMATELY 60 MPH AT THE TIME OF IMPACT AND ROLLED COMING TO REST ON ITS TOP. THE COT WAS REPORTED TO HAVE STAYED LOCKED IN THE FASTENER; HOWEVER, THE PATIENT CAME LOOSE FROM THE RESTRAINTS. IT WAS STATED THE PATIENT'S LARGE BODY SIZE DID MAKE IT DIFFICULT TO RESTRAIN THE PATIENT TO THE COT. IT WAS ALSO STATED THE PATIENT'S CONDITION PRIOR TO THE MVA WAS LISTED AS CRITICAL. THERE HAVE BEEN NO ALLEGATIONS OF PRODUCT MALFUNCTION OR FAILURE. THE EMS COMPANY HAS BEEN CONTACTED TO CONFIRM THE REPORT, SEEK ADDITIONAL INFORMATION AND OBTAIN THE SERIAL NUMBER OF THE COT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648829 35X PROFLEXX 35X PROFLEXX FPO FERNO-WASHINGTON, INC. 0015690

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death