| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00015-1 |
| Product Name/Description |
PM7100 INVOS Reusable Sensor Cables
Part Number: PMAC71RSC
Lot Number: 2023-05-04
ARTG 304037
(Medtronic Australasia Pty Ltd - Medical device electrical cable, general purpose) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/01/2024 |
| Responsible Entity |
|
| Reason/Issue |
Customer reports identified manufacturing defects within the PMAC71RSC sensor cable connector. These defects can lead to “check sensor” or “replace sensor” error messages, which result in a non-functioning channel that cannot obtain a regional oxygen saturation (rSO2) reading when using an affected cable. Based on engineering analysis, the manufacturing defects were also confirmed to potentially lead to inaccurate rSO2 readings. Inaccurate readings on these affected cables are typically biased low but may also read high. The magnitude of inaccuracy has been observed to vary by 1 to 45 rSO2 percentage points from expected value, with 1-10 rSO2 percentage points being most common.
As of 18-Dec-2023 there have been 121 complaints for PMAC71RSC worldwide that are potentially related to this issue. None of these complaints indicated patient harm occurred due to the INVOS PM7100 cables. |
| Recall Action |
Recall |
| Recall Action Instructions |
Quarantine and stop using all product from the affected lot of INVOS Reusable Sensor Cable PMAC71RSC. Affected product should be returned to Medtronic.
Medtronic will proactively send free replacement cables to those customers with impacted product (based on prior shipments) at the earliest product availability. |
| Contact Information |
0402 897 410 - James Woodin |