Company: Respironics California Inc
Date of Enforcement Report:5/10/2006
Class:l
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 PLVC 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. PLVC 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, Recall # Z-0808-6
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.
CODE
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., Carlsbad, CA, by letters on March 20, 2006. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
191 units
DISTRIBUTION
Nationwide and Internationally
