BEUDAMED
    FDA Adverse Event Death Summary report: N

    35X PROFLEXX

    MDR report key: 7548560 · Received May 29, 2018

    Report

    Report Number
    1523574-2018-00022
    Event Type
    Death
    Date Received
    May 29, 2018
    Date of Event
    May 20, 2018
    Report Date
    July 3, 2018
    Manufacturer
    FERNO-WASHINGTON, INC.
    Product Code
    FPO
    UDI-DI
    00190790000332
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COT WAS RETURNED TO MANUFACTURER FOR EVALUATION. A VISUAL AND FUNCTIONAL EVALUATION WAS CONDUCTED BY A QUALITY ENGINEER AND IT WAS DETERMINED THE COT WAS FUNCTIONING AS INTENDED WITH NO OBSERVED MALFUNCTIONS. IT WAS CONFIRMED THE MATTRESS BEING USED DID NOT HAVE MATTRESS CLIPS; HOWEVER, THE MATTRESS SHOULD STILL REMAIN IN POSITION ON THE COT DUE TO THE SIDEARMS, THE RESTRAINTS AND THE MATTRESS STOP AT THE FOOT END OF THE COT. DETAILS OF THE ACTIVITIES OCCURRING DURING THE LOADING PROCESS WERE NOT PROVIDED; THEREFORE, A DETERMINATION OF A CONTRIBUTING FACTOR TO THE INCIDENT COULD NOT BE IDENTIFIED.. THE COMPLAINANT DID CONFIRM THE POLICE WERE DOING CPR ON THE PATIENT PRIOR TO THE ARRIVAL OF THE EMS CREW INDICATING THE PATIENT WAS IN CARDIAC ARREST PRIOR TO THE REPORTED INCIDENT. INSTRUCTIONS ARE PROVIDED IN THE IFU ON PROPER TECHNIQUE IN TRANSFERRING A PATIENT ONTO THE COT.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE LOADING A PATIENT ONTO THE COT, THE MATTRESS ALLEGEDLY SLID AND THE PATIENT SLID TO THE GROUND.. THE PATIENT WAS PLACED BACK ONTO THE COT WITHOUT FURTHER INCIDENT. THE COT WAS APPROXIMATELY AT MID THIGH LEVEL WHEN THE PATIENT WAS BEING LOADED. IT WAS STATED THE PATIENT PASSED AWAY; HOWEVER, THE PATIENT'S CONDITION PRIOR TO THE ALLEGED INCIDENT WAS REPORTED AS TRAUMATIC CARDIAC ARREST.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE LOADING A PATIENT ONTO THE COT, THE MATTRESS ALLEGEDLY SLID AND THE PATIENT SLID TO THE GROUND. THE PATIENT WAS PLACED BACK ONTO THE COT WITHOUT FURTHER INCIDENT. THE COT WAS APPROXIMATELY AT MID THIGH LEVEL WHEN THE PATIENT WAS BEING LOADED. IT WAS STATED THE PATIENT PASSED AWAY; HOWEVER, THE PATIENT'S CONDITION PRIOR TO THE ALLEGED INCIDENT WAS REPORTED AS TRAUMATIC CARDIAC ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390879 35X PROFLEXX 35X PROFLEXX FPO FERNO-WASHINGTON, INC. 0015710 00190790000332

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Death