BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERFLEXX POWERED COT

    MDR report key: 4993491 · Received August 11, 2015

    Report

    Report Number
    1523574-2015-00077
    Event Type
    Malfunction
    Date Received
    August 11, 2015
    Report Date
    August 27, 2015
    Manufacturer
    FERNO-WASHINGTON, INC.
    Product Code
    FPO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL AND FUNCTIONAL EVALUATION OF THE DEVICE WAS CONDUCTED ON 8/13/2015 BY FERNO'S AUTHORIZED FIELD SERVICE COMPANY. THE TECHNICIAN COULD NOT DUPLICATE THE ALLEGED INCIDENT AND THE COT WAS FUNCTIONING ACCORDING TO SPECIFICATION. THE CUSTOMER STATED THEY COULD NOT DUPLICATE THE INCIDENT AFTER THE INITIAL REPORT. THE CUSTOMER CONFIRMED THEY HAVE NOT RECEIVED ANY ADDITIONAL INFORMATION REGARDING INJURY TO THE PATIENT AS A RESULT OF THE INCIDENT. THE COT HAS REMAINED IN SERVICE WITH NO FURTHER ISSUES. A HISTORICAL REVIEW OF THE DEVICE SERIAL NUMBER REVEAL NO PRIOR COMPLAINTS OF SIMILAR NATURE. SERVICE RECORDS HAVE BEEN REVIEWED AND NO ADDITIONAL SERVICES HAVE BEEN PERFORMED ON THE COT BY FERNO'S AUTHORIZED TECHNICIANS. AFTER INVESTIGATION, IT IS DETERMINED THIS IS NOT AN MDR INCIDENT.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A PATIENT UNLOAD FROM THE TRUCK, THE UNIT ALLEGEDLY MISSED THE SAFETY BAIL AND DROPPED TO THE TRUCK BUMPER. THE PATIENT WAS STRAPPED TO A BACKBOARD ON THE STRETCHER FOR STANDARD PROTOCOL PROCEDURES DUE TO BEING INVOLVED IN A MOTOR VEHICLE ACCIDENT. NO INJURIES WERE REPORTED AS A RESULT OF THE ALLEGED INCIDENT. A FOLLOW UP CALL WAS MADE TO INQUIRE ABOUT THE PATIENT AND IT WAS REPORTED THE HOSPITAL INITIALLY INDICATED NO INJURIES AND NO FURTHER FEEDBACK HAS BEEN PROVIDED. THE CUSTOMER STATED THEY TRIED TO DUPLICATE THE INCIDENT BACK AT THE STATION BUT THE COT FUNCTIONED NORMALLY. THE CUSTOMER HAS KEPT THE COT IN SERVICE AND HAS EXPERIENCED NO FURTHER ISSUES. EVALUATION OF THE DEVICE IS PENDING AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523959 POWERFLEXX POWERED COT POWERFLEXX POWERED COT FPO FERNO-WASHINGTON, INC. 0015651

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR