Events

Safety Alert Or Field Safety Notices for HeartStart MRx defibrillator/monitor

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Philips.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Event ID
    MDA/2014/024
  • Event Number
    CON428361
  • Date
    2014-06-26
  • Event Date Posted
    2014-06-26
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON428361?tabName=allTabs
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
  • Extra notes in the data
  • Reason
    Risk of delay in delivering cpr. when the heartstart mrx is used with the q-cpr meter in defibrillation mode, the meter may incorrectly display the ‘do not touch the patient’ icon. consequently, the user might not resume chest compressions in a timely manner, which could affect patient outcome. this problem can occur in aed or manual modes. philips issued a field safety notice dated april 2014 (reference fsn86100128a). when the heartstart mrx is in aed mode, the q-cpr meter is designed to display the ‘do not touch the patient’ icon during the shock advisory analysis period. if the user continues to deliver chest compressions when the shock advisory analysis begins, the ‘do not touch the patient’ icon may incorrectly remain on the screen after analysis or shock delivery is complete. when the heartstart mrx is in manual mode, the q-cpr meter is designed to display the ‘do not touch the patient’ icon when the device is charging to the selected energy. if the clinician continues to provide chest compressions while the device is charging, the q-cpr meter ‘do not touch the patient’ icon may incorrectly remain on the screen after shock delivery is complete. note: the mrx shock advisory decision and shock delivery continue to be executed correctly in all modes in aed mode the mrx continues to re-analyze for the shock advisory decision every two minutes with the exception of cpr meter feedback, all other mrx voice prompts including ‘resume cpr’ and ‘pause, analyzing’ operate as intended.
  • Action
    Identify any affected devices in your possession, using the Field Safety Notice. You can continue to use your HeartStart MRx without the Q-CPR meter attached. If you use the HeartStart MRx with the Q-CPR meter attached and the Q-CPR meter displays the ‘Do Not Touch the Patient’ icon at an unexpected time, follow the MRx instructions for use and remove the meter from the patient and continue CPR according to local protocol. Philips will contact you to arrange to install the software upgrade.

Device

HeartStart MRx defibrillator/monitor
  • Model / Serial
  • Product Description
    HeartStart MRx defibrillator/monitor. Model numbers M3535A and M3536A with Q-CPR™ meter option B08. Specific serial numbers affected. Affected MRx units have to meet all of the three criteria below: serial numbers from US00100153 to US00571587 inclusive the Q-CPR Meter Option B08 installed Software revision F.xx, R.xx, T.00.00 or T.00.01 installed
  • Manufacturer
    Philips

Manufacturer

Philips
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    MHRA