Events

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

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
    35056
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0808-06
  • Fecha de inicio del evento
    2006-03-20
  • Fecha de publicación del evento
    2006-05-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-04-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45200
  • 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 - Product Code CBK
  • Causa
    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.
  • Acción
    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.

Device

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

Manufacturer

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