BEUDAMED
    FDA Adverse Event Injury Summary report: N

    35 X PROFLEXX

    MDR report key: 7113017 · Received December 13, 2017

    Report

    Report Number
    1523574-2017-00056
    Event Type
    Injury
    Date Received
    December 13, 2017
    Date of Event
    December 2, 2017
    Report Date
    January 22, 2018
    Manufacturer
    FERNO-WASHINGTON, INC.
    Product Code
    FPO
    UDI-DI
    00190790000332
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    EMERGENCY MEDICAL TECHNICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COT WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. A VISUAL AND FUNCTIONAL EVALUATION WAS CONDUCTED; HOWEVER, THERE WERE NO OBSERVATIONS OF ANYTHING WHICH WOULD CONTRIBUTE TO THE COT TIPPING TO THE SIDE WHILE BEING LOADED. THE COT WAS FUNCTIONING ACCORDING TO SPECIFICATION. NO ADDITIONAL DETAILS WERE PROVIDED REGARDING THE ALLEGED PATIENT INJURY. THE COMPLAINANT ORIGINALLY REPORTED THE PATIENT SHIFTED THEIR WEIGHT DURING THE LOADING PROCESS AND IT HAS BEEN DETERMINED THIS WAS THE CONTRIBUTING FACTOR TO THE REPORTED INCIDENT. THE IFU FOR THE COT PROVIDES SUFFICIENT INSTRUCTIONS ON THE PROPER RESTRAINING OF A PATIENT TO REDUCE MOVEMENT AS WELL AS GUIDANCE ON THE REQUIRED OPERATORS AND THEIR POSITIONS NECESSARY FOR THE LOADING PROCESS TO ENSURE CONTROL OF THE COT THROUGHOUT THE PROCESS.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED WHILE ATTEMPTING TO LOAD A PATIENT, THE PATIENT SHIFTED THEIR WEIGHT CAUSING THE STRETCHER TO ALLEGEDLY TIP TO THE RIGHT SIDE. IT WAS REPORTED THE PATIENT REMAINED ON THE STRETCHER AND NEVER MADE CONTACT WITH THE GROUND. THE PATIENT COMPLAINED OF KNEE PAIN ALLEGED FROM PRESSURE AGAINST THE RESTRAINT. NO FURTHER DETAILS WERE PROVIDED.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED WHILE ATTEMPTING TO LOAD A PATIENT, THE PATIENT SHIFTED THEIR WEIGHT CAUSING THE STRETCHER TO ALLEGEDLY TIP TO THE RIGHT SIDE. IT WAS REPORTED THE PATIENT REMAINED ON THE STRETCHER AND NEVER MADE CONTACT WITH THE GROUND. THE PATIENT COMPLAINED OF KNEE PAIN ALLEGED FROM PRESSURE AGAINST THE RESTRAINT. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893160 35 X PROFLEXX 35 X PROFLEXX FPO FERNO-WASHINGTON, INC. 0015710 00190790000332

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other