BEUDAMED
    FDA Adverse Event Injury Summary report: N

    93H PROFLEXX H FRAME COT

    MDR report key: 5029790 · Received August 25, 2015

    Report

    Report Number
    1523574-2015-00079
    Event Type
    Injury
    Date Received
    August 25, 2015
    Date of Event
    August 18, 2015
    Report Date
    January 4, 2016
    Manufacturer
    FERNO-WASHINGTON, INC.
    Product Code
    FPO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    EMERGENCY MEDICAL TECHNICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE STRETCHER WAS EVALUATED ON 8/26/2015. THE STRETCHER WAS FOUND TO BE JAMMED IN A POSITION BELOW THE LOWEST POSITION. IT WAS FOUND THE PLUNGER PIN HAD BEEN JAMMED. ONCE THE PIN WAS UNJAMMED AND THE PIN HOUSING WAS RETURNED TO A NORMAL POSITION, THE COT OPERATED AS INTENDED. THE STRETCHER WAS TESTED WITH 200LBS AND FUNCTIONED ACCORDING TO SPECIFICATION. THE INCIDENT COULD NOT BE DUPLICATED. THERE WAS NO OBSERVATION OF ANY DAMAGE TO THE COT OR THE SURROUNDING COMPONENTS. IT COULD NOT BE DETERMINED WHAT CAUSED THE PIN TO BECOME JAMMED. THE EMT WAS INITIALLY SEEN AT THE HOSPITAL FOR THE ALLEGED INJURY; HOWEVER, SHE WAS ABLE TO RETURN TO WORK WITHOUT MISSED TIME. NO FOLLOW UP INFORMATION HAS BEEN PROVIDED ABOUT LONG TERM INJURY. FERNO DID PROVIDE USE TRAINING TO THE CREW MEMBERS TO ASSURE PROPER OPERATION OF THE STRETCHER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE COT WAS IN THE INTERMEDIATE POSITION AND A PATIENT WAS IN THE PROCESS OF GETTING OFF THE COT, THE COT ALLEGEDLY DROPPED TO THE LOWEST POSITION AND STRUCK THE FOOT OF THE ATTENDING EMT. THE CUSTOMER STATED THE EMT HAD HER FOOT ON THE LEG OF THE COT TO STABILIZE IT FOR THE PATIENT AND WHEN IT LOWERED IT CAUGHT HER FOOT BETWEEN THE UPPER AND LOWER LEG PORTIONS. THE EMT ALLEGED A CONTUSION TO HER FOOT. THE CUSTOMER WAS CONTACTED AND THEY CONFIRMED THE EMT DID SEEK MEDICAL INTERVENTION AT THE HOSPITAL AND WAS RELEASE WITH ONLY MINOR SWELLING AND WAS ABLE TO RETURN TO WORK WITH NO MISSED TIME. THE CUSTOMER ALSO REPORTED THERE WAS NO INJURIES TO THE PATIENT. THE DEVICE EVALUATION IS PENDING AND RESULTS WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE COT WAS IN THE INTERMEDIATE POSITION AND A PATIENT WAS IN THE PROCESS OF GETTING OFF THE COT, THE COT ALLEGEDLY DROPPED TO THE LOWEST POSITION AND STRUCK THE FOOT OF THE ATTENDING EMT. THE CUSTOMER STATED THE EMT HAD HER FOOT ON THE LEG OF THE COT TO STABILIZE IT FOR THE PATIENT AND WHEN IT LOWERED IT CAUGHT HER FOOT BETWEEN THE UPPER AND LOWER LEG PORTIONS. THE EMT ALLEGED A CONTUSION TO HER FOOT. THE CUSTOMER WAS CONTACTED AND THEY CONFIRMED THE EMT DID SEEK MEDICAL INTERVENTION AT THE HOSPITAL AND WAS RELEASE WITH ONLY MINOR SWELLING AND WAS ABLE TO RETURN TO WORK WITH NO MISSED TIME. THE CUSTOMER ALSO REPORTED THERE WAS NO INJURIES TO THE PATIENT. THE DEVICE EVALUATION IS PENDING AND RESULTS WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559869 93H PROFLEXX H FRAME COT 93H PROFLEXX H FRAME COT FPO FERNO-WASHINGTON, INC. 0015758

    Patients

    Seq Age Sex Outcome Treatment
    1 Other