Class 1 Device Recall PLV Continuum Ventilator

• Date Initiated by Firm: March 20, 2006
• Date Posted: May 02, 2006
• Recall Status: Terminated on April 21, 2008
• Recall Number: Z-0808-06
• Recall Event ID: 35056
• 510(K)Number: K022750
• Product Classification: Ventilator - Product Code CBK
• Product: 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 has a membrane keypad with indicator Light Emitting Diodes for the selection and acceptance of patient settings and for the display of alarm conditions. PL VC I provides the following types of ventilatory support: 1) Positive Pressure Ventilation, delivered either invasively (via endotracheal or tracheostomy tube) or non-invasively (via mask or mouthpiece ). 2) Assist/Control, Spontaneous Intermittent Mandatory Ventilation (SIMV)or Continuous Positive Airway Pressure (CPAP) modes of ventilation. 3) Volume-Controlled (VC). Available in AlC and SIMV. 4) Pressure-Controlled (PC). Available in AlC and SIMV. 5) Pressure Support (PS). Available in SIMV and SPONT.
• Code Information: DOMESTIC DISTRIBUTION: VS4702502, VS4700835, VS4700809, VS4700653, VS4700833, VS4700819, VS4700580, VS4700776,VS4700554, VS4700754, VS4702535, VS4702512,VS4702523, VS4702556, VS4702568, VS4700608, VS4700729, VS4700760, VS4700620, VS4702586, VS4702677, VS4702750, VS4702784, VS4702848, VS4700773, VS4700852, VS4700549, VS4700552, VS4700555, VS4700569, VS4700643, VS4700681, VS4700718, VS4700823, VS4700836, VS4702776, VS4700802, VS4700588, VS4700789, VS4700849, VS4700622, VS4700642, VS4702604, VS4700687, VS4700838, VS4702528, VS4702545, VS4700663, VS4700694, VS4700725, VS4700822, VS4700853, VS4702572, VS4700624, VS4700738, VS4702553, VS4702570, VS4700566, VS4700578, VS4702591, VS4700558, VS4700615, VS4702800, VS4702505, VS4700783, VS4700791, VS4700821, VS4702580, VS4700774, VS4702589, VS4700834, VS4700840, VS4700596, VS4700785, VS4700846, VS4702501, VS4702519, VS4702548, VS4700786, VS4702650, VS4702590, VS4700565, VS4702525, VS4702557, VS4702574, VS4700767, VS4700721, VS4702594, VS4702709, VS4700724, VS4700814, VS4702573, VS4700824, VS4700536, VS4700574, VS4700585, VS4700595, VS4700625, VS4700698, VS4700736, VS4700744, VS4700827, VS4700855, VS4702555, VS4702575, VS4700842, VS4700790, VS4700544, VS4702552, VS4702567, VS4702571, VS4700843, VS4702566, VS4700650, VS4700811, VS4700817, VS4700850, VS4702857, VS4700635, VS4700796, VS4700816, VS4700649, VS4702689, VS4702583, VS4702981, VS4702551, VS4702532, VS4702543, VS4702599, VS4700708, VS4702600, VS4702811, VS4700770, VS4702623, VS4700673, VS4700617, VS4700539, VS4700548, VS4700646, VS4700660, VS4700739, VS4700590, VS4700577, VS4702859, VS4700782, VS4700780, VS4700614, VS4702647, VS4702805, VS4700813, VS4702688, VS4700844, VS4700607, VS4700847, VS4700841, VS4702809. INTERNATIONAL DISTRIBUTION: VS4700553, VS4700628, VS4700645, VS4700717, VS4702915, VS4702962, VS4703006, VS4703023, VS4703041, VS4703056, VS4703064, VS4702500, VS4702828, VS4702858, VS4700792, VS4702605, VS4702608, VS4702609, VS4702631, VS4702632, VS4702634, VS4702642, VS4702643, VS4702659, VS4702719, VS4702754, VS4702759, VS4702722, VS4700696, VS4700601, VS4700563, VS4700644, VS4700839, VS4702645, VS4703027.
• Recalling Firm/ Manufacturer: Respironics California Inc; 2271 Cosmos Ct; Carlsbad CA 92009-1517
• For Additional Information Contact: Mary Funk; 760-918-7328
• Manufacturer Reason for Recall: 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.
• FDA Determined 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 PLV 100, 102 or 102b Ventilator with no charge. If patient support goes beyond the capabilities of the PLV 100, 102, or 102b Ventilator is required, Respironics will make arrangements to loan the customer with a suitable substitute rental ventilator at no charge. The field action will involve the upgrade of all affected devices with a new flow valve assembly. All US and International units are being recalled to the factory in Carlsbad, California. The rework will be conducted on-site.
• Quantity in Commerce: Domestic (235) + International Distribution (42)=277 units
• Distribution: Nationwide, plus Australia, Argentina, Canada, Japan, Hong Kong, Netherlands, Saudi Arabia, & Taiwan
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = CBK