Recall Z-0808-06 ยท CBK Ventilator, Continuous, Facility Use
Respironics California Inc
Ventilator-PLV Continuum (PLVC I), Model Number: P1000. The PLVC I is a microprocessor controlled, compressor-based, mechanical ventilator. It is intended to control or assist breathing by delivering room air to the patient. It utilizes an internal compressor to generate compressed air for delivery to the patient. Breath delivery is controlled by software algorithms. The PL VC I user interface
| Date | May 2, 2006 (initiated Mar 20, 2006) |
| Status | Terminated |
| Reason | Flow valve failures- When failure occurs, air flow from the ventilator ceases resulting in the PLVC I transitioning into a 'Vent Inop' mode whereby the safety valve is activated, opening the circuit to ambient air. Ventilator dependent patients may not receive adequate ventilatory support if this problem occurs. |
| Root cause | Other |
| Action | Notification letters were mailed to customers on March 20, 2006 notifying them of this action. Customers were instructed to quarantine all PLV Continuum Ventilators in their possession and not to place patients on them. Respironics Customers Service will contact customers to arrange for the return of all PLV Continuum Ventilators. Customers were instructed to safely plan and transition patients in their care from the PLV Continum Ventilator onto to other comparable patient support devices. If customers did not have a suitable ventilator to use for their patients, Respironics will loan them a P |
| Quantity | Domestic (235) + International Distribution (42)=277 units |
| Distribution | Nationwide, plus Australia, Argentina, Canada, Japan, Hong Kong, Netherlands, Saudi Arabia, & Taiwan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022750 | PLV CONTINUUM VENTILATOR, MODEL P1000 Respironics California, Inc., Nov 20, 2003 |