BEUDAMED
    FDA Adverse Event Death Summary report: N

    !!93P AMBULANCE COT

    MDR report key: 6193120 · Received December 21, 2016

    Report

    Report Number
    1523574-2016-00038
    Event Type
    Death
    Date Received
    December 21, 2016
    Date of Event
    December 16, 2016
    Report Date
    February 10, 2017
    Manufacturer
    FERNO-WASHINGTON, INC.
    Product Code
    FPO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    EMERGENCY MEDICAL TECHNICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COT WAS EVALUATED BY AN AUTHORIZED FIELD TECHNICIAN AT THE COMPLAINANT'S SITE. A VISUAL AND FUNCTIONAL EVALUATION WAS CONDUCTED AND IT WAS OBSERVED THE NECESSARY HARDWARE ON THE AUXILLIARY LOCK RELEASE WAS MISSING WHICH DID NOT ALLOW THE RELEASE STRAP TO ENGAGE AND FUNCTION AS INTENDED. THE FIELD TECHNICIAN INSTALLED NEW HARDWARE AND TESTED ALL FUNCTIONS. THE COT WAS OPERATING PER SPECIFICATION AND WAS RETURNED TO SERVICE. THE COT IN QUESTION WAS 9+ YEARS OLD AT THE TIME OF INCIDENT. THE USER MANUAL FOR THE DEVICE DOES PROVIDE INSTRUCTION TO INSPECT ALL HARDWARE TO ENSURE EVERYTHING IS SECURELY IN PLACE FOR PROPER OPERATION OF THE COT.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE ON SCENE FOR A UNCONSCIOUS, NO RESPIRATION AND NO PULSE PATIENT, THE PATIENT WAS PLACED ON A BACKBOARD AND CPR WAS COMMENCED. THE PATIENT WAS THEN LOADED ONTO THE COT AND WHEELED TO THE AMBULANCE. UPON ATTEMPTING TO RAISE THE LEGS OF THE STRETCHER TO LOAD THE COT INTO THE AMBULANCE THE LEGS WOULD ALLEGEDLY NOT DISENGAGE. THE LOAD PROCESS WAS ATTEMPTED MULTIPLE TIMES BUT THE UNDERCARRIAGE WOULD ALLEGEDLY STILL NOT RELEASE. THE PATIENT WAS THEN REMOVED FROM THE COT AND TRANSPORTED IN THE AMBULANCE WITH THE BACKBOARD. THE STRETCHER WAS LEFT BEHIND AT THE SCENE AND WAS LATER TRANSPORTED BACK TO THE STATION BY ANOTHER MEDIC UNIT IN THE FULLY EXTENDED POSITION. IT WAS REPORTED A DELAY IN TRANSPORT RESULTED FROM THE INCIDENT BUT THE PATIENT'S CONDITION DID NOT CHANGE FROM THE TIME THEY ARRIVED ON SCENE TO THE TIME THEY ARRIVED AT THE HOSPITAL. FURTHER REPORTS OF THE OUTCOME OF THE PATIENT HAVE NOT BEEN RECEIVED TO DATE. THE STRETCHER HAS BEEN REMOVED FROM SERVICE AND AN INVESTIGATION HAS BEEN INITIATED TO EVALUATE THE REPORTED INCIDENT.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE ON SCENE FOR A UNCONSCIOUS, NO RESPIRATION AND NO PULSE PATIENT, THE PATIENT WAS PLACED ON A BACKBOARD AND CPR WAS COMMENCED. THE PATIENT WAS THEN LOADED ONTO THE COT AND WHEELED TO THE AMBULANCE. UPON ATTEMPTING TO RAISE THE LEGS OF THE STRETCHER TO LOAD THE COT INTO THE AMBULANCE THE LEGS WOULD ALLEGEDLY NOT DISENGAGE. THE LOAD PROCESS WAS ATTEMPTED MULTIPLE TIMES BUT THE UNDERCARRIAGE WOULD ALLEGEDLY STILL NOT RELEASE. THE PATIENT WAS THEN REMOVED FROM THE COT AND TRANSPORTED IN THE AMBULANCE WITH THE BACKBOARD. THE STRETCHER WAS LEFT BEHIND AT THE SCENE AND WAS LATER TRANSPORTED BACK TO THE STATION BY ANOTHER MEDIC UNIT IN THE FULLY EXTENDED POSITION. IT WAS REPORTED A DELAY IN TRANSPORT RESULTED FROM THE INCIDENT BUT THE PATIENT'S CONDITION DID NOT CHANGE FROM THE TIME THEY ARRIVED ON SCENE TO THE TIME THEY ARRIVED AT THE HOSPITAL. FURTHER REPORTS OF THE OUTCOME OF THE PATIENT HAVE NOT BEEN RECEIVED TO DATE. THE STRETCHER HAS BEEN REMOVED FROM SERVICE AND AN INVESTIGATION HAS BEEN INITIATED TO EVALUATE THE REPORTED INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842597 !!93P AMBULANCE COT !!93P AMBULANCE COT FPO FERNO-WASHINGTON, INC. 0015642

    Patients

    Seq Age Sex Outcome Treatment
    1 Other