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HeartStart MRx Monitor/Defibrillator
Notice type:
Advisory
Date:
31/03/2014
Product name or type:
HeartStart MRx Monitor/Defibrillator
Reference:
SN2014(15)
Manufacturer Or Supplier:
Philips Healthcare
Target Audience:
Paramedics
Ambulance Headquarters
Medical directors
Risk managers
Supplies managers
General practitioners
Private medical practitioners
Clinics
Hospitals
Nursing Homes
Please bring this safety notice to the attention of all who need to be aware of it.
Problem Or Issue:
A number of technical issues that Philips have identified with the Heartstart MRx Monitor/Defibrillator may result in the device not being able to deliver therapy when required.
Background Information Or Related Documents:
HeartStart MRx Monitor/Defibrillator Document
Philips has identified and highlighted through the attached field safety notices (FSNs) a number of issues that may result in the HeartStart MRx Monitor/Defibrillator not being able to deliver therapy when required.
FSN861000127: Therapy Board Failure
An internal component on the HeartStart MRx may malfunction potentially affecting the ability to deliver therapy. Please see the attached field safety notice that provides information on how to identify affected devices and instructions on actions to be taken. To correct this issue Philips will provide a replacement therapy board to customers with affected units free of charge.
Affected Product: Philips HeartStart MRx Monitor/Defibrillator, model numbers M3535A, M3536A, M3536M, M3536M4, M3536M6, 861288, 861289, 861464, 861483, and 861491.
Units Affected: Serial numbers within the range US00100204 to US00570921.
FSN86100128: Meter May Provide Incorrect CPR Instructions
When the HeartStart MRx is used with the Q-CPR Meter in defibrillation mode, the Q-CPR Meter may incorrectly display the “Do Not Touch the Patient” icon. Philips is initiating a software upgrade that will be provided to customers free of charge.
Affected Product: Philips HeartStart MRx Monitor/Defibrillator, model numbers M3535A and M3536A with Q-CPR™ Meter Option B08 Serial numbers within the following ranges: MRx units with the Q-CPR Meter option B08 and with a serial number within the range: US00100253 and US00571587.
FSN86100131: Processor Board Failure
A component of the MRx Processor Board may be susceptible to damage from electrostatic discharge (ESD), which can disrupt ECG and SpO2 functionality leading to an inability to perform:
• Demand mode pacing
• 12 lead ECG acquisition and analysis
• ECG monitoring via leads
• Pulse oximetry (SpO2)
Defibrillation, fixed mode pacing and ECG monitoring via pads/paddles are not impacted by this issue. Philips is initiating a hardware upgrade that will be provided to customers free of charge. A Philips Healthcare representative will contact you to arrange for installation of the hardware upgrade.
Affected Product: Philips HeartStart MRx Monitor/Defibrillator, model numbers M3535A, M3536A, M3536J, M3536MC.
Serial numbers within the following ranges:
Model M3535A: US00100100 to US00541372
Model M3536A: US00100902 to US00541375
Model M3536J: US00209838 to US00332675
Model M3536MC: US00500001 to US00500020
FSN86100132: Monitor/Defibrillator Therapy Connection Could Experience Accelerated Wear
When used in hospital transport and pre-hospital (EMS) environments, the therapy connection could experience accelerated wear. This wear could cause the MRx to misidentify the pads therapy cable, external paddles, or internal paddles when they are connected to the MRx therapy port, which could pose a risk for patients and/or caregivers.
Please see the attached field safety notice that provides information on how to identify affected devices and instructions on actions to be taken. To correct this issue Philips will perform a free of charge inspection and hardware upgrade.
Affected Product: Philips HeartStart MRx Monitor/Defibrillator, model numbers M3535A, M3536A, M3536J, M3536M and M3536MC.
MRx devices and serial numbers within the following ranges:
Model M3535A – US00100104 – US00572207
Model M3536A – US00100902 – US00543688
Model M3536J – US00209838 – US00332675
Model M3536M – US00500002 – US00500009
Model M3536MC – US00500002 – US00500028
CIL86100134: M3538A Lithium Ion Batteries
The Philips HeartStart MRx Monitor/Defibrillator, when operating on battery power only, may experience an unexpected shutdown if exposed to elevated levels of electromagnetic interference from RF energy sources.
Please see the attached Customer Information Letter that provides information on how to identify affected batteries and instructions on actions to be taken. To correct this issue, Philips will replace affected HeartStart MRx M3538A Lithium Ion batteries free of charge.
Affected Product: Philips HeartStart MRx Lithium Ion batteries (M3538A Revision J) with the following serial numbers affected:
11327-0019-P
11315-0023-P
11315-0027-P
11315-0031-P
11315-0032-P
11315-0033-P
11315-0036-P
11315-0109-P
11315-0214-P
11315-0219-P
11315-0391-P
11322-0084-P
11322-0088-P
11327-0043-P
11327-0044-P
Or within the following range: 11335-xxxx-P to 13214-xxxx-P
FSN86100135: Leads ECG Cable Connection Could Experience Accelerated Wear
When used in hospital transport and pre-hospital (EMS) environments the MRx leads ECG connector block port / trunk cable connection could experience accelerated wear.
Please see the attached field safety notice that provides information on how to identify affected devices and instructions on actions to be taken.
To correct this issue, Philips is initiating a hardware upgrade that will be provided to customers free of charge.
Affected Product: Philips HeartStart MRx Monitor/Defibrillator, model numbers M3535A, M3536A, M3536J, M3536M, M3536M5, and M3536MC
Units Affected: Serial numbers within the range US00100100 - US00550668
The IMB is issuing this Safety Notice to ensure all HeartStart MRx users are aware of these issues. Please note that not all devices are affected by the issues outlined above.
Actions To Be Taken:
1. Ensure that all device users are aware of the information provided in the attached field safety notices issued recently by Philips.
2. Work with the local distributor to ensure that your device receives the relevant upgrades as soon as possible.
Further Information:
Enquiries in relation to this action may be addressed to the Irish distributor:
Cardiac Services
128 Slaney Road
Glasnevin
Dublin 11
Telephone: +353-1-8307499
E-mail:
recall@cardiac-services.com
All adverse incidents relating to a medical device should be reported to the:
Health Products Regulatory Authority
Kevin O’Malley House
Earlsfort Centre
Earlsfort Terrace
Dublin 2
Telephone: +353-1-6764971
Fax: +353-1-6344033
E-mail:
devicesafety@hpra.ie
Website:
www.hpra.ie
Please click here to view a PDF version of this Safety Notice
Please click here to view FSN 1
Please click here to view FSN 2
Please click here to view FSN 3
Please click here to view FSN 4
Please click here to view FSN 5
Please click here to view FSN 6
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Date Printed: 20/04/2024