Alerta De Seguridad para HeartStart MRx Defibrillator, Models M3535A / M3536A Registration 10216710136, serial numbers: Attachment.

Safety alert

1459

2014-11-17

Brazil

ANVISA

http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp

Problem 1: mrx may be susceptible to interference from fast electrical transients (efts) when connected to ac or dc power, operating through a lan cable or operating near an eft interference source, which could cause a delay in therapy or have it delivered incorrectly. issue 2: if a user runs one of two atypical clinical workflows, the mrx may exhibit unexpected behavior. these workflows do not conform to the instructions in the mrx instructions for use (ifu), and are not expected to be performed by trained physicians. in addition, these behaviors were only observed during internal tests, and were not reported during clinical use. workflows are as follows: workflow a: when using external paddles for defibrillation, the mrx can deliver the shock when only one of the two shock buttons is pressed if the user performs the following sequence: 1. mrx in use with 2. press and hold a single button on the external "apex" paddle and turn the therapy button to any other clinical mode (monitor, pacer, aed) 3. user releases the button being held in the outer paddles 4. user transforms the mrx back to any manual setting and presses charge 5. the user inadvertently presses the button on the other outer paddle "sternum". the mrx will deliver a shock with this single button pressed. the ability to collide with a single button pressed will continue until the device is turned off. note: apex and sternum blades may be changed to reproduce the problem. workflow b: when using the periodic data transmission (pcdt) option in the mrx, the mrx can restart if the user performs the following sequence: 1. in monitor mode with pcdt on and in transmission, the user toggles monitor mode for manual defibrillation mode. 2. while the screen is in transition from monitor mode to manual defibrillation mode, the user presses the sync button. 3. the mrx will reboot, rebooting in 6-8 seconds. problem 3: the mrx could stop pacing search mode due to an ecg leads-off condition when the electrode-to-skin contact impedance values ​​are outside the limits specified for detection.

The company informs that the MRx equipment can be used before receiving the software update, as long as the guidelines given below are followed. Problem 1 - If interference is to occur: - Users may experience the symptoms described below, and may take the actions listed to resume operation. (Note: these symptoms may occur for other clinical reasons not related to electrical interference). i) Symptom: When loaded, MRx disarms unexpectedly, and displays a "Defib Disarm" message and an audio tone. - Action: To recharge the device, press the charge button. ii) Symptom: When in stimulation, the MRx displays a "Stopped Pacing" message, displays a "Pads Off" or "Pads Cable Off" message, and gives an alarm. - Action: Check that the pads are correctly applied to the patient. Check the cable connections. Press the Resume Pacing soft key to resume pacing. • There is a possibility of accidental discharge when using internal switched blades. To mitigate the associated risks, users should ensure that before loading the MRx, the internal paddles are correctly applied to the patient and the user is not touching the patient or shovel. Issue 2: Ensure that users are aware that the two workflows described in the "Problem description" section of this Security Warning may lead to unexpected device behavior and therefore should not be performed. Problem 3: The MRx will display the message "Pacing stopped.Leads off" when pacing was interrupted due to detection of a lead-off condition or an ECG cable disconnection (Note: this message may be displayed for non-clinical reasons. related to the problem described in this Safety Warning.) If this message appears in pacing search mode, users can choose one of the following to resume pacing if desired: i) Solve the lead-off condition as described in Instructions for use of the MRx: "Check that the monitoring electrodes are correctly applied to the patient. Check the cable connections. Press the Resume Pacing softkey to continue pacing. Ii) Change the pacing mode to "fixed" using the following steps: 1. With the therapy button in the Pacer position, press the Select Menu button to activate the main menu . 2. Use the navigation buttons to select Pacer mode and press the select button in the menu to confirm. 3. Use the Navigation Buttons to select Fixed and press the select button in the menu to confirm.