| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00980-1 |
| Product Name/Description |
DreamStation Auto CPAP - Care Orchestrator
AUX500S15
Serial number: J32217410F40C
ARTG 295664
(Philips Electronics Australia Ltd - Home CPAP unit) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
15/11/2023 |
| Responsible Entity |
|
| Reason/Issue |
An error has been detected in the Philips Respironics Care Orchestrator prescription programming that caused Care Orchestrator to provide non-current device settings or failed updated prescription settings to one therapy device in Australia.
This update failure may have resulted in old prescriptions being delivered to the patient C-PAP device. (Serial number: J32217410F40C).
It is unlikely that the therapy device user would detect any changes to the prescription settings on the sleep therapy device, whereas users of the Care Orchestrator software (CPAP providers) may notice a discrepancy activity in the stored patient records.
The result of a stale prescription being delivered to a patient has the potential to result in insufficient or excessive therapy and patient discomfort.
There haven't been reported cases of patient harm to date, but the affected device may still be used. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
CPAP providers must:
-Review the Patient Activity Log (PAL) in Care Orchestrator for the device affected and adjust the device settings if clinically required.
Device settings may be adjusted directly on the therapy device or within Care Orchestrator if the affected device is still being used with a modem (such that device settings may be updated in Care Orchestrator and sent to the modem).
-Contact their CPAP patients to confirm that the CPAP device has the correct device settings applied.
Philips Respironics has taken steps to prevent future occurrences. However, is currently unable to correct the device settings, as these are set by the provider and patient needs may have changed since the issue occurred. |
| Contact Information |
1800 830 517 - Philips Electronics Australia Ltd |