HeartStart MRx Monitor - Defib with Q-CPR Additional Infomation to Instructions for Use July 2015.pdf
Emergency Care and Resuscitation
Customer Information Letter
Philips HeartStart MRx Monitor/Defibrillator with Q-CPR
Additional Information to Instructions for Use
Philips has updated the HeartStart MRx’s Instructions for Use associated with Q-CPR meter and CPR
sensor via an addendum. The addendum has instructions on application of the disposable adhesive
pads, which are used with the Q-CPR meter, including a diagram which illustrates proper placement and
orientation of this pad. In addition, the addendum includes general information on the types of injuries,
which may occur during CPR.
Please refer to the following page, which provides additional information about these updates. Please
follow the instructions provided in the “Actions to be taken by Customer/User” section. If you need any
further information or support concerning this update, please contact your local Philips representative :
<Philips representative contact details to be completed by the KM / country>
General Manager, Emergency Care and Resuscitation
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Product: Q-CPR meter and CPR sensor used with Philips HeartStart MRx
Monitor/Defibrillator with Q-CPR option.
Units Affected: All Q-CPR meter and CPR sensor, models 453564145481,
453564257691, and M4761A are affected.
REASON FOR UPDATE
During internal review, Philips identified that the instructions on attaching the QCPR meter adhesive pad to the Q-CPR meter could be improved.
Patient chest injury:
Instructions did not inform the users that properly performed CPR can result in
injuries to the patient.
HOW TO IDENTIFY
Q-CPR meter or CPR sensor used with Philips HeartStart MRx Monitor/Defibrillator
with Q-CPR Option are affected.
Q-CPR meter Model # 453564145481 and 453564257691
CPR sensor Model # M4761A
The model number is printed on the back of the meter and sensor, as shown
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ACTIONS TO BE
TAKEN BY CUSTOMER
Provide the information in the attached HeartStart MRx IFU Addendum to users.
ACTIONS PLANNED BY
Philips is issuing an Addendum to the HeartStart MRx IFU to provide additional
guidance on proper use of the Q-CPR meter and CPR sensor.
If you need any further information or support concerning this issue, please
contact your local Philips representative: <Philips representative contact
details to be completed by the KM / country>
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