All Pace Medical Inc temporary pacemakers and pacing system analysers (PSAs) 를 위한 안전성 경고 / 현장 안전성 서한

Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.

These devices are currently not on the EU market. Their CE-marking has been suspended because of quality system failings.In April 2014, Pace Medical’s subcontractor Devices Ltd, was audited by its notified body, BSI, with MHRA present as the observer. The audit found significant quality system failings relating to processes for complaint handling, post-market surveillance and vigilance, which included failures to implement corrective actions agreed at previous audits. As a result of this, on 9 April, the notified body suspended the EC-certification covering all devices manufactured by Pace Medical, except the pacing cables. Servicing of devices already in the field is unaffected by the suspension of the EC certificate.We are aware that UK hospitals use a range of temporary pacing cables and heart wires with temporary pacemakers. However, Pace Medical only holds validation data to confirm compatibility of their own cables with their pacemakers. Hospitals should continue to make a risk-based decision on the use of alternative, reusable or disposable cables or heart wires, based on availability and clinical need.The manufacturer is working with its notified body to prepare a corrective action plan to address the identified issues. The notified body will need to complete follow-up audits of Pace Medical’s actions before the EC-certification can be restored. If the situation changes, MHRA will issue further information.