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Terminated

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.

FDA Recall Z-0485-2015 · Posted 2014-12-01

Recalling FirmRespironics California Inc
Recall StatusTerminated
Product CodeCBK
Date Initiated2014-10-29
Date Terminated2016-06-07
Product Quantity3,943 units total (3,071 units in US)

Reason for Recall

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.

Firm Action

Philips Healthcare sent an Urgent - Field Safety Notice to all affected consignees to inform them that Respironics is recalling the Esprit V1000 and Esprit/V200 Conversion ventilators because 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. A high urgency audible alarm will sound alerting medical personnel of the loss of power. In the absence of AC power, failure of battery power will cause loss of ventilator support, which may result in hypercarbia or hypoxemia. The potential issue affects ventilators manufactured prior to 12/31/04 due to design of the fan/shroud assembly. Esprit V1000 and Esprit/V200 Conversion Ventilators manufactured after that affected date are not affected. Customers with concerns were instructed to contact a Philips Respironics representative at (800) 722-9377. For questions regarding this recall call 760-918-7300.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Ecuador, Egypt, Greece, Hong Kong, India, Italy, Korea, Lebanon, Malaysia, Mexico, Pakistan, Panama, Peru, Philippines, Saudi Arabia, Singapore, South Africa, Spain, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Vietnam, and Yemen.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041412ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000Respironics California, Inc. · 2004-06-18K034040ESPRIT VENTILATOR, MODEL V1000Respironics, Inc. · 2004-01-21K023350ESPRIT VENTILATOR WITH RESPIRATORY MECHANICSRespironics California, Inc. · 2002-11-06K001208ESPIRTRespironics, Inc. · 2000-05-12K981072ESPRIT VENTILATORRespironics, Inc. · 1998-11-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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