FDA Adverse Event Malfunction Summary report: N

Q-STRESS

MDR report key: 4226042 · Received September 30, 2014

Report

Report Number
4226042
Event Type
Malfunction
Date Received
September 30, 2014
Date of Event
September 4, 2014
Report Date
September 30, 2014
Manufacturer
MORTARA INSTRUMENT, INC
Product Code
IOL
Product Problem
Yes
Report Source
User Facility report
Reporter Location
RI, US

Narratives

Description of Event or Problem · 1

PATIENT WAS EXERCISING ON A TREADMILL DURING A STRESS ECHOCADIOGRAM. THE PATIENT EXERCISED 10 MINUTES AND 30 SECONDS. THE NURSE TOLD THE PATIENT THAT SHE WAS GOING TO STOP THE TREADMILL AND INSTRUCTED THE PATIENT TO LIE DOWN QUICKLY ONCE THE TREADMILL STOPPED. THE NURSE CLICKED THE "STOP BELT" ICON ON THE SCREEN. THE BELT PAUSED MOMENTARILY AND THE PATIENT ATTEMPTED TO LIE DOWN. THE NURSE WAS ASSISTING THE PATIENT ONTO THE TABLE WHEN THE BELT STARTED TO ACCELERATE. THE PATIENT LOST HIS BALANCE AND FELL ONTO THE MOVING TREADMILL BELT. THE PATIENT FELL ONTO HIS RIGHT ELBOW. THE NURSE ALSO FELL AT THIS POINT IN AN EFFORT TO AVOID PATIENT INJURY. THE SONOGRAPHER HIT THE TWO RED "STOP" BUTTONS ON THE KEYBOARD. THE TREADMILL BELT STOPPED. THE PATIENT WAS ATTEMPTING TO GET UP WHEN THE BELT STARTED TO ACCELERATE AGAIN. THE PATIENT THEN HIT HIS NECK ON THE TREADMILL BELT. THE SONOGRAPHER THEN HIT THE EMERGENCY STOP BUTTON WHICH COMPLETELY STOPPED THE TREADMILL BELT FROM MOVING. THE PATIENT WAS THEN ASSISTED ONTO THE TABLE BY THE NURSE AND SONOGRAPHER. I WAS THEN NOTIFIED OF THIS EVENT AND WENT INTO THE EXAM ROOM TO ASSIST. I ASKED THE CARDIOLOGY FELLOW TO COME INTO THE STRESS ROOM TO ASSESS THE PATIENT. THE PATIENT HAD SEVERAL ABRASIONS LOCATED ON HIS RIGHT LOWER BACK, HIP, RIGHT ELBOW AND RIGHT NECK. THE CARDIOLOGY FELLOW CONTACTED THE ATTENDING CARDIOLOGIST WHO RECOMMENDED THAT WE BRING THE PATIENT TO THE ED FOR FURTHER ASSESSMENT. WE MONITORED THE PATIENT FOR APPROXIMATELY 15 MINUTES POST EVENT AND THEN TRANSPORTED HIM TO THE ED VIA WHEELCHAIR.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
609697 Q-STRESS TREADMILL, POWERED IOL MORTARA INSTRUMENT, INC * *

Patients

Seq Age Sex Outcome Treatment
1 58 YR