| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00656-1 |
| Product Name/Description |
HeartStart Intrepid Monitor/Defibrillator
With the 12-lead option: B03
Product Identifier: 867294
ARTG 281589
(Philips Electronics Australia Ltd - Physiologic-monitoring defibrillation system) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
2/08/2024 |
| Responsible Entity |
|
| Reason/Issue |
When monitoring ECG using either a 5-Lead or 10-Lead ECG cable, the HeartStart Intrepid Monitor/Defibrillator may display intermittent ECG waveforms when the fourth limb lead is placed on the patient. The ECG tracing is normal when only three limb leads are connected (right arm, left arm, and left leg). However, when there are one or more poor ECG lead connections to the patient, the ECG tracing either displays a dashed line or is intermittent between waveform and dashed line. This failure may occur any time the HeartStart Intrepid Monitor/Defibrillator is being used to monitor 5-Lead or 12-Lead ECG.
This problem may lead to delayed treatment or medical intervention for the patient. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Philips is currently working on a solution for this problem. Customers will be notified when a permanent solution is available, which is expected in Q4 2024.
Customers in the meantime are to:
- If gaps in the ECG waveform are experienced, remove the Right Leg and Chest connections to force the device to default to 3-Lead measurement and ensure a continuous ECG during monitoring, pacing, or cardioversion.
- Continue to follow the Instructions for Use (IFU) for proper use of ECG electrodes and their application to patients, including skin preparation. Use only Philips approved lead sets listed in the IFU with the HeartStart Intrepid.
- Use only Philips monitoring electrodes, multifunction electrode pads, battery, and accessories listed in the IFU. |
| Contact Information |
1800 251 400 - Philips Service Delivery Team |