BEUDAMED
    FDA Adverse Event Summary report: N

    93H PROFLEXX AMBULANCE COT

    MDR report key: 6130534 · Received November 28, 2016

    Report

    Report Number
    1523574-2016-00031
    Date Received
    November 28, 2016
    Date of Event
    October 6, 2016
    Report Date
    December 16, 2016
    Manufacturer
    FERNO-WASHINGTON, INC.
    Product Code
    FPO
    UDI-DI
    00190790000417
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    EMERGENCY MEDICAL TECHNICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED BY A FIELD TECHNICIAN AT THE COMPLAINANT'S SITE. A VISUAL AND FUNCTIONAL EVALUATION WAS CONDUCTED AND NO ISSUES OR PROBLEMS WERE DETECTED AND THE COT WAS OPERATING ACCORDING TO SPECIFICATION. THE COT WAS TESTED AND RETURNED TO SERVICE. NO FURTHER INFORMATION REGARDING THE MEDIC'S ALLEGED INJURY HAS BEEN PROVIDED. IT CANNOT BE DETERMINED IF THE ALLEGED INJURY WAS SERIOUS IN NATURE.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE TRANSPORTING A (B)(6) PATIENT ON THE STRETCHER, THE STRETCHER HIT A SMALL BUMP ON THE RESIDENTS DARK PATHWAY AND THE COT ALLEGEDLY LOWERED APPROXIMATELY 12 INCHES. THERE WAS NO REPORT OF ANY INJURY TO THE PATIENT; HOWEVER, AN EMT IS ALLEGING A SHOULDER INJURY. THE COMPLAINANT WAS CONTACTED AND IT WAS REPORTED THE MEDIC SOUGHT BASIC FIRST AID FOR THE ALLEGED INJURY. AN INVESTIGATION HAS BEEN INITIATED TO EVALUATED THE REPORTED INCIDENT.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE TRANSPORTING A 300-400LB PATIENT ON THE STRETCHER, THE STRETCHER HIT A SMALL BUMP ON THE RESIDENTS DARK PATHWAY AND THE COT ALLEGEDLY LOWERED APPROXIMATELY 12 INCHES. THERE WAS NO REPORT OF ANY INJURY TO THE PATIENT; HOWEVER, AN EMT IS ALLEGING A SHOULDER INJURY. THE COMPLAINANT WAS CONTACTED AND IT WAS REPORTED THE MEDIC SOUGHT BASIC FIRST AID FOR THE ALLEGED INJURY. AN INVESTIGATION HAS BEEN INITIATED TO EVALUATED THE REPORTED INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779990 93H PROFLEXX AMBULANCE COT 93H PROFLEXX AMBULANCE COT FPO FERNO-WASHINGTON, INC. 0015762 00190790000417

    Patients

    Seq Age Sex Outcome Treatment
    1 Other