| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00650-1 |
| Product Name/Description |
Philips V60 non-invasive ventilator
All ventilators with a date of manufacture prior to15 September 2015
ARTG Number: 285664 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
23/05/2017 |
| Responsible Entity |
|
| Reason/Issue |
Philips has identified an issue with an internal cable of the Philips V60 non-invasive ventilator manufactured prior to 15 September 2015. Over time, low-frequency vibrations can cause the pins within the female connectors on the internal Motor Controller to Data Acquisition Board ribbon cable to become partially displaced, which causes momentary high resistance that interferes with data transfer. This may cause the ventilator to fail Power on Self Testing (POST) or cause Continuous Built in Test (CBIT) to detect a fault and lead to a ventilator shut down with alarm during use or during intra-hospital transport.
If a Vent Inop event occurs when a patient is connected, pressure support and O2 delivery will cease. Such cessation may cause the patient’s SpO2 to drop and, if the alarm is not attended to promptly, may lead to Hypoxemia or Hypercarbia.
There have been two reported deaths and nine reports of harm/injury from overseas jurisdictions. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
To minimise risks of illness or injury, users are requested to operate the V60 as directed or recommended in the operator’s manual, including by:
· Promptly attending to all alarms presented by the V60 Ventilator;
· Using an external O2 monitor/analyser and setting the alarm thresholds appropriately;
· Ensuring the correct circuits and masks identified in the operator’s manual are used with the V60;
· Wherever possible, connecting the V60 to a remote call system; and
If the V60 Shuts down, alarms, and displays any of the error codes 100A, 1006, 1007, or 1008, then (i) turn the V60 off, (ii) discontinue use of the V60, and (iii) use an alternate ventilator. Call your local customer service contact and report the failure. Please reference FCO86600037A.
The incidence of failure is low but there is significant risk if it occurs. In deciding whether to continue using the V60, facilities should consider their monitoring and response capabilities or an alternative ventilator.
This action has been closed out on 15/11/2018 |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |