Device Recall Respironics PLV Continuum

  • 모델명 / 제조번호(시리얼번호)
    Domestic Distribution Serial Numbers: VS4700581, VS4700661, VS4700631, VS4702578, VS4702507, VS4702551, VS4702583, VS4702589, VS4702590, VS470259], VS4702574, VS4702580, VS4702566, VS4700824, VS4702593, VS4700835, VS4700536, 1VS4700539, VS4700540, VS4700543, VS4700544, S4700546, VS4700548, VS4700549, VS4700550, VS4700552,VS4700554, VS4700555, VS4700558, VS4700565, VS4700566,VS4700567, VS4700569, VS4700573, VS4700574, VS4700577,VS4700578, VS4700580, VS4700581, VS4700585, VS4700588VS4700590, VS4700593, VS4700594, VS4700595, VS4700596, VS4700605, VS4700607, VS4700608, VS4700613, VS4700614, VS4700615, VS4700617, VS4700620, VS4700622, VS4700624, VS4700625, VS4700632, VS4700635, VS4700637, VS4700642, VS4700643, VS4700646, VS4700647, VS4700649, VS4700650, VS4700653, VS4700660, VS4700661, VS4700663, VS4700668, VS4700670, VS4700673, VS4700681, VS4700687, VS4700693, VS4700694, VS4700698, VS4700699, VS4700708, VS470071O, VS4700711, VS4700718, VS4700719, VS4700721, VS4700724, VS4700725, VS4700729, VS4700730, VS4700736, VS4700738, VS4700739, VS4700740, VS4700743, VS4700744, VS4700750, VS4700751, VS4700754, VS4700760, VS4700761, VS4700762, VS4700767, VS4700770, VS4700772, VS4700773, VS4700774, VS4700775, VS4700776, VS4700777, VS4700780, VS4700781, VS4700782, VS4700783, VS4700785, VS4700786, VS4700789, VS4700790, VS4700791, VS4700796, VS4700797, VS4700798, VS4700802, VS4700804, VS4700808, VS4700809, VS4700811, VS4700813, VS4700814, VS4700816, VS4700817, VS4700818, VS4700819, VS4700821, VS4700822, VS4700823, VS4700827, VS4700828, VS4700829, VS4700832, VS4700833, VS4700834, VS4700836, VS4700837, VS4700838, VS4700840, VS4700841, VS4700842, VS4700843, VS4700844, VS4700846, VS4700847, VS4700849, VS4700850, VS4700852, VS4700853, VS4700854, VS4700855, VS4700856, VS4702501, VS4702502, VS4702505, VS4702512, VS4702516, VS4702519, VS4702523, VS4702524, VS4702525, VS4702528, VS4702531, VS4702532, VS4702535, VS4702543, VS4702544, VS4702545, VS4702548, VS4702549, VS4702552, VS4702553, VS4702555, VS4702556, VS4702557, VS4702567, VS4702568, VS4702570, VS4702571, VS4702572, VS4702573, VS4702575, VS4702586, VS4702594, VS4702599, VS4702600, VS4702604, VS4702612, VS4702613, VS4702623, VS4702636, VS4702647, VS4702650, VS4702670, VS4702677, VS4702688, VS4702689, VS4702709, VS4702734, VS4702747, VS4702748, VS4702750, VS4702776, VS4702784, VS4702800, VS4702805, VS4702809, VS4702811, VS4702813, VS4702825, VS4702835, VS4702848, VS4702854, VS4702856, VS4702857, VS4702859, VS4702883, VS4702885, VS4702981, VS4703079, VS4703103  International Distribution Serial Numbers: VS4702605, VS4702608, VS4702609, VS4702631, VS4702632, VS4702634, VS4702642, VS4702643, VS4702659, VS4702719, VS4702754, VS4702759, VS4700792, VS4702722, VS4700563, VS4700696, VS4700820, VS4700601, VS4702645, VS4700839, VS4700644, VS4700589, VS4700703, VS4700723, VS4700746, VS4700553, VS4700628, VS4702962, VS4702983, VS4702995, VS4703006, VS4703023, VS4703041, VS4703056, VS4703064, VS4700717, VS4700645, VS4702915, VS4702500, VS4702828, VS4702858
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide, Taiwan, Saudi Arabia, Netherlands, Hong Kong, Canada, Brazil, Australia, and Argentina.
  • 제품 설명
    The PL V Continuum ventilator is a microprocessor controlled, compressorbased, mechanical ventilator. It is intended to control or assist breathing by delivering room air to the patient. PL V Continuum utilizes an internal compressor to generate compressed air for delivery to the patient. Breath delivery is controlled by software algorithms. The user interface on PL V Continuum has a membrane keypad with indicator Light Emitting Diodes (LED) for the selection and acceptance of patient settings and for the display of alarm conditions. PL V Continuum is capable of providing the following types of ventilatory support: || . Positive Pressure Ventilation, delivered either invasively (via endotracheal or tracheostomy tube) or non-invasively (via mask or mouthpiece). || . Assist/Control, Spontaneous Intermittent Mandatory Ventilation (SIMV) or Continuous Positive Airway Pressure (CP AP) modes of ventilation. || . Volume-Controlled (VC). Available in AlC and SIMV. || . Pressure-Controlled (PC). Available in AlC and SIMV. || . Pressure Support (PS). Available in SIMV and SPONT.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Respironics California Inc, 2271 Cosmos Ct, Carlsbad CA 92009-1517
  • Source
    USFDA