| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01482-1 |
| Product Name/Description |
Lifepak15 Monitor/Defibrillator with End-tidal CO2 Option
ARTG Number: 215648 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
11/11/2016 |
| Responsible Entity |
|
| Reason/Issue |
Physio-Control has become aware that the display of the LIFEPAK 15 respiratory rate may partially obscure a portion of the leading digit of the EtCO2 value when using EtCO2 in the kPa or % setting mode and in a situation where the reading is above 9.9 kPa. Although only part of the first digit of the EtCO2 value is obscured by the respiratory rate, the capnography waveform scale automatically adapts to the EtCO2 value. Observing the capnography waveform and the range displayed will help the user confirm the patient’s EtCO2 value. Clinical misinterpretation of a low EtCO2 value when the value is actually high could potentially lead to incorrect treatment and/or delays in clinical decision making. There have been no reports of incorrect patient treatment or harm associated with this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Physio-Control is requesting users to:-
1. Forward this information to all associated sites, trainers and users that may have a LIFEPAK 15 monitor/defibrillator;
2. In the event staff use LIFEPAK 15 monitor/defibrillator to display EtCO2 values they should also display the EtCO2 waveform which includes the range along the right side of the display;
3. In the event staff use either kPa or % settings, they should activate EtCO2 alarms to identify EtCO2 values outside the normal range; and
4. If local protocols allow this option, consider changing the EtCO2 to measure in the mmHg setting.
Once a permanent correction is developed Physio-Control will post information on our website when an updated software version is available.
This action has been closed out on 08/01/2020 |
| Contact Information |
1800 987 982 - Physio-Control |