Respironics California, Inc

Reports per year

Source: FDA adverse event reports by year received, 2005–2021. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Top device categories

• Sv70 VentilatorMNT21,050
• Ventilator, Continuous, Facility UseCBK6,087
• Ventilator, Continuous, Non-Life-SupportingMNS375
• Automated External Defibrillators (Non-Wearable)MKJ12
• OximeterDQA1

Recent recalls

• 2017-05-18TerminatedDevice Design

  Philips V60 Ventilators, Material No. 850008, 1053613, 1053614, 1053615, 1053616, 1053617, 1076715, 1076716, 1076717, DU1053617, U1053617. Old Material No. 850008, 989805628251, 989805612101, 989805613391, 989805613661, 989805611761, 989805627411, 989805627431, 989805627441, 989805616411, 989805636631.

  Over time, low-frequency vibrations can cause the pins within the female connectors on the Motor Controller to Data Acquisition Board ribbon cable to become partially displaced causing momentary high resistance that prevents or restricts data travelling through the cable during the high resistance event.

• 2014-12-01TerminatedDevice Design

  Esprit V1000 Ventilator and Esprit/V200 Conversion Ventilator The Esprit V1000 and Esprit/V200 Conversion Ventilators are microprocessor-controlled, electrically powered mechanical ventilators. Intended for use by medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients.

  If the power supply fan mounting screws are installed incorrectly, the ends of the screws may touch the power supply printed circuit board assembly (PCBA) and short to ground. This may prevent the ventilator to switch to battery power if AC power is disrupted.

• 2014-10-21TerminatedUnknown/Undetermined by firm

  Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits Microprocessor-controlled, electrically powered mechanical ventilators intended for use by qualified medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients as prescribed by a physician.

  A failure of a specific component may prevent the ventilators from operating on AC power or transitioning back to AC power when operating on battery. Additionally, if a battery is not present or is depleted the ventilators will not operate. This failure will cause the loss of ventilator support, which may result in hypercarbia or hypoxemia.

• 2013-08-26TerminatedDevice Design

  Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics, Model No. V1000

  The power to the Esprit Display's Backlight is interrupted, causing the GUI to flicker or go dark and making the display unreadable.

• 2013-06-17TerminatedSoftware design

  Respironics V60 Ventilator, Model #V60 Respironics Material P/N (Philips 12 Digit P/N): 85008 (85008) 1053613 (989805628251) 1053614 (989805612101) 1053615 (989805613391) 1053616 (989805613661) 1053617 (989805611761) 1053618 (n/a) R1053618 (n/a) 1076709 (n/a) 1076715 (989805627411) 1076716 (989805627431) 1076717 (989805627441) DU1053617 (989805616411) U1053614 (989805636441) U1053617 (989805636631) Power Mgmt. Board, Respironics Material P/N: 1054358, Philips 12 Digit P/N: 4536561512581. The V60 Ventilator is an assist Ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician. The V60 Ventilator is intended to support pediatric patients weighing 20kg (44 lbs.) or greater to adult patients. It is also intended for intubated patients meeting the same selection criteria as the noninvasive applications. It is intended to be used by qualified medical professionals, such as physicians, nurses, and respiratory therapists.

  Respironics California, Inc. has initiated a recall on the V60 ventilator because of an issue with the software on the V60 Power Management Board Assembly. If a component fails on the Power Management Board Assembly, it may cause ventilator support to be lost with potentially no audible alarm from the ventilator.

• 2012-08-31TerminatedNonconforming Material/Component

  V60 Ventilator, Continuous Ventilator, Model# V60, PN 1056490 Product Usage: The V60 Ventilator is an assist Ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician. The V60 Ventilator is intended to support pediatric patients weighing 20kg (44 Ibs) or greater to adult patients. It is also intended for intubated patients meeting the same selection criteria as the noninvasive applications. It is intended to be used by qualified medical professionals, such as physicians, nurses, and respiratory therapists.

  Respironics is recalling the V60 ventilator because certain blower motor assemblies in the V60 ventilators may not meet specifications. Specifically, the impeller may not be properly seated on the blower motor shaft. This could subsequently cause the blower to cease functioning which would result in the failure of the V60 ventilator to deliver therapy to the patient due to the loss of ventilatio

• 2010-11-24TerminatedDevice Design

  Respironics V60 Ventilator, manufactured by Respironics California Inc. in Carlsbad, CA.

  Respironics California Inc has received customer complaints of an odor or burning smell coming from the V60 Ventilator, and identified a component on the Power Management PCB that exhibited thermal damage.

• 2009-11-11TerminatedDevice Design

  RESPIRONICS V60 VENTILATOR

  The recall was initiated to correct an issue with a component on the V60 Ventilator Power Management (PM) Printed Circuit Board (PCB). A component on the PCB has the potential to break off or become damaged if the PCB is removed from the ventilator. If this occurs, the ventilator may not properly switch between back up battery power and AC power. This can result in power loss during ventilation fo

• 2009-08-11TerminatedDevice Design

  Respironics Esprit Ventilator System, Model Number V1000 with Optional External Battery; Product Number: 1001456.

  The recall was initiated because through routine product monitoring Respironics discovered that under certain conditions, when operating on AC line power, a portion of the current from the External Battery charger is erroneously diverted to the ventilator. When this occurs, the External Battery charger may not transition correctly. Prolonged operation in this condition results in overcharging and

• 2009-07-07TerminatedComponent design/selection

  Respironics BiPAP Focus Noninvasive Ventilator System. The BiPAP Focus is a non-invasive, pressure support ventilator used to augment the breathing of patients suffering from acute or chronic respiratory insufficiency, respiratory failure or to maintain airway patency and provide respiratory support to patients who experience obstructive sleep apnea. Nasal and full face masks are used with this device. The BiPAP Focus is intended for use in acute, sub-acute and intra-hospital transport settings.

  Power Supply failures have occurred on some ventilators. A discrepancy between the power supply strain relief clip and the power cord connector may allow unwanted movement of the cord and the unit's power supply. A disconnection or intermittent electrical connection between the power cord and the unit's power supply during operation or charging can result in transient power surges, which may cau