Events

Retiro De Equipo (Recall) de Device Recall Respironics PLV Continuum

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Respironics California Inc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    34129
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0354-06
  • Fecha de inicio del evento
    2005-11-18
  • Fecha de publicación del evento
    2006-01-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-04-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43173
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Ventilator, Continuous, Facility Use - Product Code CBK
  • Causa
    During product testing of the plv continuum ventilator's safety valve/pressure relief valve (sv/prv) at our manufacturing facility, respironics found that when the ply continuum ventilator is operated in the 'face up' orientation, the sv /prv may stick in the open position, which may result in loss of delivered gas volume to the patient.
  • Acción
    On November 18, 2005 all affected customers received a personal phone call from Respironics explaining the recall situation in detail. On November 21, 2005, an advisory notice was sent to customers via fax, email, or mail, instructing customers to only use your PLV Continuum Ventilator in the 'Face Foward' orientation. The firm will contact customers with further information shortly to assure that this situation is positively resolved. Customers were instructed to Only use the PL V Continuum Ventilator in the 'Face Forward' orientation. In the event that a customer requires the application of the PLV Continuum Ventilator in the Face Up Orientation, Respironics will provide the customer, at no charge, with a rental PLV-l00, PLV-IO2b or PLV-I02 Ventilator for the customer to use until their PLV Continuum Ventilator is upgraded. If additional information is needed the customer was instructed to contact Respironics'' Customer Service at 800 345-6443.

Device

Device Recall Respironics PLV Continuum
  • Modelo / Serial
    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
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide, Taiwan, Saudi Arabia, Netherlands, Hong Kong, Canada, Brazil, Australia, and Argentina.
  • Descripción del producto
    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
    Respironics California Inc

Manufacturer

Respironics California Inc
  • Dirección del fabricante
    Respironics California Inc, 2271 Cosmos Ct, Carlsbad CA 92009-1517
  • Source
    USFDA