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Recall Observatory FDA recall evidence

Device product

Respironics RP-Touch Screen, V60/V680 Ventilator Serviced with Touchscreen RP Kit 453561511951 containing a touchscreen labeled as raw part number 1132318 Revision C

Z-1154-2020

September 11, 2019

Class II

Product summary

Firm
Respironics California, LLC
Event
Event 83980
Status
Ongoing
Classification
Class II
Quantity
800
Official record key
device-enforcement:Z-1154-2020

Official wording

Reason: Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requires a change in therapy, there is no warning associated with an unresponsive touchcreen, and therefore the clinician would have no prior indication of a touchscreen failure and would be unable to change ventilator settings. The ventilator will continue to function at the predetermined and accepted settings required to support the patient. A delay in therapy adjustments may result in hypercarbia and/or hypoxemia.

Code information: Touchscreen Serial Number: 41088-1808-0001 to 0179, 41213-1809-0001 to 0200, 41305-1811-0001 to 0295, 41379-1812-0001 to 0250, 41379-1812-0251 to 0328, 41540-1813-0001 to 0195, 41633-1814-0001 to 0275, 41633-1814-0276 to 0285, 41724-1815-0001 to 0140, 41724-1815-0141 to 0183, 41838-1816-0001 to 0107, 41838-1816-0108 to 0165, 41930-1817-0001 to 0092, 42059-1818-0001 to 0150, 42059-1818-0151 to 0183, 42161-1819-0001 to 0117, 42161-1819-0118 to 0137, 42232-1820-0001 to 0130, 42232-1820-0131 to 0146, 42334-1822-0001 to 0134, 42334-1822-0135 to 0141, 42471-1823-0001 to 0143, 42471-1823-0144 to 0175, 42805-1828-0001 to 0138

Distribution pattern: US Nationwide. OUS (Foreign): Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Finland, France, Germany, Greece, Hong Kong, Iceland, India, Indonesia, Israel, Italy, Malaysia, Mexico, Netherlands, Portugal, Singapore, South Africa, Spain, Sweden, United Arab Emirates, United Kingdom, Viet Nam, Oman, Philippines, Saudi Arabia, Taiwan, Turkey, Russian Federation, Argentina, Ecuador, Poland, Guatemala, Peru, Viet Nam

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requires a change in therapy, there is no warning associated with an unresponsive touchcreen, and therefore the clinician would have no prior indication of a touchscreen failure and would be unable to change ventilator settings. The ventilator will continue to function at the predetermined and accepted settings required to support the patient. A delay in therapy adjustments may result in hypercarbia and/or hypoxemia.