BEUDAMED
    FDA Adverse Event Summary report: N

    !!35-P PROFLEXX AMBULANCE COT

    MDR report key: 6132474 · Received November 29, 2016

    Report

    Report Number
    1523574-2016-00034
    Date Received
    November 29, 2016
    Date of Event
    November 16, 2016
    Report Date
    January 31, 2017
    Manufacturer
    FERNO-WASHINGTON, INC.
    Product Code
    FPO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    EMERGENCY MEDICAL TECHNICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN AUTHORIZED FIELD TECHNICIAN EVALUATED THE COT AT THE COMPLAINANT'S LOCATION. THE TECHNICIAN DID ALERT THE MANUFACTURER THAT THE INCORRECT SERIAL NUMBER WAS PROVIDED AT THE ONSET OF THIS COMPLAINT. THE CORRECT SERIAL NUMBER OF THE COT INVOLVED IN THE INCIDENT WAS PROVIDED. A VISUAL AND FUNCTIONAL EVALUATION WAS CONDUCTED AND THE REPORTED MALFUNCTION COULD NOT BE DUPLICATED. THE TECHNICIAN FOUND NOTHING WRONG WITH THE COT THAT WOULD CAUSE IT TO DROP A POSITION ON ITS OWN. THE COT WAS 13+YEARS OLD AT THE TIME OF INCIDENT AND THE COMPLAINANT CONFIRMED THEY DID NOT HAVE A PM PLAN IN PLACE ON THE COT. AT THE REQUEST OF THE COMPLAINANT THE TECHNICIAN CONDUCTED A PM SERVICE ON THE COT AND RETURNED IT TO SERVICE. NO FURTHER INFORMATION WAS PROVIDED REGARDING ANY LATER ALLEGED INJURIES OR MEDICAL INTERVENTION REQUIRED ON THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN ENTERING A RESIDENCE WITH A PATIENT ON BOARD THE COT THE MEDICS LOWERED THE COT TO KNEE HEIGHT POSITION. THEY THEN STEPPED AWAY FROM THE COT TO PERFORM OTHER FUNCTIONS WHEN THE COT ALLEGEDLY LOWERED TO THE LOWEST HEIGHT. THE PATIENT ALLEGEDLY COMPLAINED OF MINOR NECK PAIN BUT REFUSED A MEDICAL TRANSPORT FOR MEDICAL EVALUATION/INTERVENTION. THE COMPLAINANT WAS CONTACTED AND THEY CONFIRMED THEY HAD NOT BEEN CONTACTED BY THE PATIENT OR OTHERWISE NOTIFIED THE PATIENT SOUGHT LATER MEDICAL INTERVENTION AS A RESULT OF THE INCIDENT. THIS INCIDENT WILL BE FURTHER INVESTIGATED.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN ENTERING A RESIDENCE WITH A PATIENT ON BOARD THE COT THE MEDICS LOWERED THE COT TO KNEE HEIGHT POSITION. THEY THEN STEPPED AWAY FROM THE COT TO PERFORM OTHER FUNCTIONS WHEN THE COT ALLEGEDLY LOWERED TO THE LOWEST HEIGHT. THE PATIENT ALLEGEDLY COMPLAINED OF MINOR NECK PAIN BUT REFUSED A MEDICAL TRANSPORT FOR MEDICAL EVALUATION/INTERVENTION. THE COMPLAINANT WAS CONTACTED AND THEY CONFIRMED THEY HAD NOT BEEN CONTACTED BY THE PATIENT OR OTHERWISE NOTIFIED THE PATIENT SOUGHT LATER MEDICAL INTERVENTION AS A RESULT OF THE INCIDENT. THIS INCIDENT WILL BE FURTHER INVESTIGATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782248 !!35-P PROFLEXX AMBULANCE COT !!35-P PROFLEXX AMBULANCE COT FPO FERNO-WASHINGTON, INC. 0015614

    Patients

    Seq Age Sex Outcome Treatment
    1