| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00629-1 |
| Product Name/Description |
Philips IntelliVue Neuromuscular Transmission (NMT) Patient Cables
(Used with Philips IntelliVue NMT Module 865383 and IntelliVue Patient Monitors)
Philips IntelliVue NMT Patient Cables
Model: 989803174581
Cable also supplied in Philips IntelliVue NMT Module, Product Option #K01, Model : 865383 #K01
Cables that have CE Mark with suffix 0366
ARTG Number: 202378 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/05/2017 |
| Responsible Entity |
|
| Reason/Issue |
Investigations conducted by Philips subsequent to customer complaints have revealed that a small number of IntelliVue Neuromuscular Transmission (NMT) Patient Cables may contain a localised isolation defect in the shielding of the acceleration sensor housing. This manufacturing defect may cause localised heating due to an unintended current flow between the acceleration sensor housing attached to the patient thumb and the NMT stimulation electrode connection attached to the wrist of the same hand. Using a defective NMT Patient Cable on a patient under anaesthesia who receives repeated NMT stimulations during a procedure may result in a localised skin burn of up to several millimetres in diameter. |
| Recall Action |
Recall |
| Recall Action Instructions |
Philips is requesting customers to identify all affected cables by checking their inventory for NMT patient cables that bear the CE mark with the suffix "0366". The affected stock is to be removed from inventory and quarantined. Customers will be contacted by a Philips Healthcare representative or an authorised service provider to arrange for a visit to replace the affected cables.
This action has been closed out on 15/11/2018 |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |