| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00485-1 |
| Product Name/Description |
Capnostream 20p Patient Monitors - battery pack (used for combined capnograph/pulse oximeter monitor)
INTL Capnostream 20P w/prntr
Product Code: CS08658-01
INTL Capnostream 20P N X1
Product Code: CS08652-01
Batteries manufactured between April 2014 and February 2016
ARTG Number: 207165 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/04/2016 |
| Responsible Entity |
|
| Reason/Issue |
Covidien Respiratory and Monitoring Solutions, now a part of Medtronic, is issuing a recall for the battery pack used in Oridion labelled Capnostream20p patient monitors. The scope of this recall includes battery packs that were manufactured between April 2014 and February 2016. The recall includes battery packs included with the monitors and spare replacement parts purchased separate from the monitor.
This recall is due to a supplier defect in battery manufacturing that may increase the risk of thermal damage to the battery pack.
There has been one report involving a fire resulting in smoke inhalation and minor burns to a user. |
| Recall Action |
Recall |
| Recall Action Instructions |
Medtronic is advising users to identify, remove and appropriately dispose of affected battery packs using the instructions provided. Alternatively, contact Medtronic with assistance with the disposal.
Once the batteries are removed, the Patient Monitor must be connected to AC power and can no longer be used for intra-hospital transport of patients until replacement batteries are provided. This action has been closed-out on 28/02/2017. |
| Contact Information |
1800 350 702 - Medtronic Technical Services |