| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01245-1 |
| Product Name/Description |
Esprit V1000 and Esprit/V200 Conversion Ventilator
Respironics Part Numbers: 701-01000-00, C701-01000-00, DU701-01000-00, U701-01000-00
Philips Part numbers : 989805611721, 989805643301, 989805612621, 989805613441
ARTG Number: 134845 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
21/11/2014 |
| Responsible Entity |
|
| Reason/Issue |
If the power supply fan mounting screws are installed incorrectly, the ends of the screws may touch the power supply printed circuit board assembly (PCBA) and short to ground which may prevent the ventilator to switch to battery power if AC power is disrupted. A high urgency audible alarm will sound alerting medical personnel of the loss of power. In the absence of AC power, failure of battery power will cause loss of ventilator support which could result in hypercarbia or hypoxemia. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is advising their customers to carry out a Power Fail Alarm Test as per the Operators Manual. If AC power is disrupted and the ventilator cannot switch to battery operation, a High Urgency alarm will sound and the patient must be supported with another means of life support ventilation.
A new fan installation hardware kit will be installed on affected units. A Philips Field Service Engineer will be contacting customers to schedule the installation at no-cost. This action has been closed-out on 12/08/2016. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |