Field Safety Notice Philips 12-Lead Chest Lead-set (AAMI/IEC) FJE6389 (ICN 1852)

MHRA TBC
NHS Supply Chain Reference: 57

Alert:

• The supplier Philips Medical has issued an Important Product Notice following discovery of an issue related to the orientation of the internal wiring of the Philips 12-Lead Chest Lead-set (AAMI/IEC).
• The V1 and V3 leads in the Philips 12-Lead Chest Lead-set (AAMI/IEC) were incorrectly assembled. The internal wiring of V1 and V3 leads being incorrectly positioned (swapped) in the lead-set hub generates the wrong electrocardiogram (ECG) report and potentially the wrong interpretation of the results on both the 989803151671 (12-Lead Chest Lead-set (AAMI/IEC), Std) and 989803151691 (12-Lead Chest Lead-set (AAMI/IEC), Long).
• The swapped lead-set issue is only applicable for the Page Writer TC70, TC50, and TC30 cardiographs.
• Upon setting up the electrocardiogram (ECG), there is no indication that the V1 and V3 leads have been swapped. The user will not know the lead wires are incorrectly assembled until an inaccurate electrocardiogram (ECG) result is produced.

Products Affected:

•  One of the products affected has been supplied available by NHS Supply Chain:

• Please refer to the field safety notice and online catalogue for further details on the affected product.

Next Steps:

• Read and follow the instructions in the Product Notice.
• Where leads are shown to be faulty after following steps 1,2,3 cease use and destroy.
• If the cable is displaying the correct ECG results, then the lead is not affected.
• Cardiac services advise Philips will provide instructions of how to claim a free of charge replacement once the new leads currently in production are available, estimated for February 2023.
• Not all leads are affected, customers can continue to order from cardias services’ current inventory until the new leads are available noting that the issue may affect any leads received until the new stock has been produced.
• Complete the customer response form page five of the field safety notice and return to: recall@cardiac-services.com as soon as possible.
• If you experience difficulties in carrying out the instructions in this communication, please contact your local cardiac services representative.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor.