| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00275-1 |
| Product Name/Description |
V60 Respiratory Ventilator with software version 2.20
ARTG Number: 285664 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
27/02/2017 |
| Responsible Entity |
|
| Reason/Issue |
Philips has identified that V60 Ventilators with software version 2.20 may falsely detect that the blower motor has stalled. If this condition occurs, the software will cause the ventilator to shut down (Vent Inop) and display Error Code 100E. Ventilatory support will cease. An audible high-priority alarm will sound continuously for at least 2 minutes when the V60 shuts down for any Vent Inop condition and is operating on battery power. If the V60 is connected to AC power (mains supply), the alarm will continue to sound until an operator intervenes. If the V60 is connected to a remote alarm system, the alarm system will be activated until action is taken by the operator.
Error Code 100E only exists in V60 Version 2.20 software. Therefore, V60’s running Version 2.10 software are not subject to this particular Vent Inop condition.
To date, there have been no adverse events reported due to false detection of blower motor stalls. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Phillips is advising affected facilities to discontinue use of the V60 until V2.10 s/w is installed. If no other non-invasive ventilator is available, & other methods of ventilator support are deemed inappropriate or undesirable for the patient, facilities may continue to use the V60 under the conditions below:
1. Make arrangements to have V2.10 s/w installed on affected devices ASAP.
2. To minimise risk of illness or injury, operate the V60 as defined in the operator’s manual & promptly attend to all alarms presented by the V60.
3. As recommended, use an external O2 monitor/analyser & set the alarm thresholds appropriately.
4. As recommended, ensure the correct circuits and masks identified in the operator’s manual are used with the V60.
5. Wherever possible, connect the V60 to a remote call system.
If the V60 Shuts down, alarms & displays Error Code 100E, turn the V60 off & restart the ventilator. If 100E occurs again, discontinue use of the V60 and use an alternate ventilator
This action has been closed out on 13/11/2018 |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |