Potential fault with HeartStart MRx Defibrillators

A problem has been identified by the manufacturers of the HeartStart MRx being a 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.

If you have any HeartStart MRx Defibrillators within your workplace, you are recommended to identify any affected devices in your possession.

Affected Product: Philips HeartStart MRx Monitor/Defibrillator, model numbers M3535A and M3536A with Q-CPR™ Meter Option B08

Units Affected (MRx units with ALL (1+2+3) of the following):

  1. serial number in the range US00100153 to US00571587
  2. 2. the Q-CPR Meter Option B08 installed
  3. 3. Software revision F.xx, R.xx, T.00.00 or T.00.01 installed.

NOTE: This Medical Device Correction only affects HeartStart MRx units that meet ALL of the criteria above.

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.

If you need any further information or support concerning this, please contact your local
Philips representative or the UK Philips Customer Care Service Centre on 0870 532 9741.

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