Events

Recall of Device Recall PLV Continuum Ventilator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Respironics California Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    35056
  • Event Risk Class
    Class 1
  • Event Number
    Z-0808-06
  • Event Initiated Date
    2006-03-20
  • Event Date Posted
    2006-05-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-04-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45200
  • Notes / Alerts
    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.
  • Extra notes in the data
    Ventilator - Product Code CBK
  • 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.
  • 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.

Device

Device Recall PLV Continuum Ventilator
  • Model / 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.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, plus Australia, Argentina, Canada, Japan, Hong Kong, Netherlands, Saudi Arabia, & Taiwan
  • Product Description
    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
  • Manufacturer Address
    Respironics California Inc, 2271 Cosmos Ct, Carlsbad CA 92009-1517
  • Source
    USFDA