| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00259-1 |
| Product Name/Description |
OmniLab Advanced + (OLA+) devices
OmniLab Advanced, Core, (International)
Product number: 1043342
OmniLab Advanced+ International w/ Humidifier
Product number: 1111126
OmniLab Advanced+ International w/ Heated Tube Humidifier
Product number: 1111127
Demo OmniLab Advanced plus w/HT Humidifier INTL- OBS, Discontd.
Product number: D1111127
ARTG 327227
(Philips Electronics Australia Ltd - Portable ventilator, electric) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
2/04/2024 |
| Responsible Entity |
|
| Reason/Issue |
The OmniLab Advanced + (OLA+) devices feature a Ventilator Inoperative alarm, which occurs when the ventilator detects an internal error or a condition that may affect therapy. This may manifest in the following ways:
· When there are three (3) reboots within a 24-hour period, the device will enter a Ventilator Inoperative state (therapy stopped, audible and visual alarms present).
OR
The device may enter a Ventilator Inoperative state without a reboot preceding this condition
The device will remain inoperable until a hard reboot is completed which may temporarily fix the problem.
This information supersedes the Product Defect Alert issued in April 2024. |
| Recall Action |
Product Defect Alert |
| Recall Action Instructions |
Philips Respironics is currently investigating this problem and will implement appropriate actions to prevent recurrence once known.
In the interim patients/users are to:
-If a Ventilator Inoperative Alarm Occurs ensure the patient is connected to an alternative source of ventilation. Or contact patients home care equipment provider for service and/or an alternative device.
-As an optional step, customers may attempt a “hard reboot” that MAY temporarily restore device function until an alternative device is sourced (instructions in the customer letter).
-This can take approximately 60 seconds to perform
HCPs are to assess whether the patients under their care can tolerate interruptions of therapy to ensure they continue to receive the most appropriate therapy. Further instructions provided in the customer letter.
If further information is required, or if customers haven't heard from Philips, contact Philips on 1800 830 517 or clinical-philips@easyconnectsrc.zendesk.com. |
| Contact Information |
1800 830 517 - Philips Customer Support |