Early Alert: Ventilator Issue from CooperSurgical

CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.Affected Product The FDA is aware that CooperSurgical has issued a letter to affected customers recommending certain ventilators be removed from where they are used or sold. Affected devices:Device / Product NamePart NumberLot CodesProduct UDIINCA Infant Nasal CPAP, Complete Set44-2707550019722(01) 20888937009433INCA Infant Nasal CPAP, Complete Set44-2709550031617550033781550031621(01) 60888937009448INCA Infant Nasal CPAP, Complete Set44-2710550031615550031616550031620550034760(01) 20888937009457INCA Infant Nasal CPAP, Complete Set44-2712550031611550031614550033779550031619(01) 20888937009464INCA Infant Nasal CPAP, Complete Set44-2715550031618550033780550034763(01) 20888937009471INCA Neonatal Nasal CPAP, Replacement Set44-0712550031624(01) 60888937009516INCA Neonatal Nasal CPAP, Replacement Set44-0707550021057(01) 20888937009488INCA Neonatal Nasal CPAP, Replacement Set44-0709550031623(01) 20888937009495INCA Neonatal Nasal CPAP, Replacement Set44-0715550031625(01) 20888937009525What to DoDo not use affected product.

Identify affected product, cease use and distribution, and return to CooperSurgical.On August 11, CooperSurgical sent all affected customers a letter recommending the following actions:If the loose connection is recognized during the use of the CPAP, replace the tubing with another tubing or CPAP device.Stop further use or distribution and segregate affected productNotify relevant personnel in your facility who use these devicesIf any products have been forwarded to another facility, contact that facility and provide them with the firm’s noticeCheck this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.Reason for AlertCooperSurgical stated the units from specific lots of the INCA Neonatal Nasal CPAP Complete Set and Replacement Set may exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use. If the loose connection is not detected during assembly and/or placement, the tubing may leak at the connection to the nasal cannula or disconnect from the nasal cannula.

This can result in loss of CPAP pressure, which may reduce the effectiveness of treatment and lead to decreased oxygenation of the patient until connection is restored.As of August 11, CooperSurgical has reported no serious injuries or deaths associated with this issue.Device UseThe INCA Infant Nasal CPAP Assembly is a medical device designed to deliver continuous positive airway pressure (CPAP) to newborn and infant patients requiring respiratory support. The system consists of a clear, soft nasal cannula connected to two shapeable "Stay-Flex" tubes that maintain a fixed position to minimize patient movement and nasal trauma. The assembly includes built-in tubing adapters, an in-line pressure adapter, a knit cap with fixation straps, and a chin strap to manage air leaks and secure the circuit.Contact InformationCustomers in the U.S.

with adverse reactions, quality problems, or questions about this issue should contact CooperSurgical Recall Support Team at fieldaction@coopersurgical.com or 203-895-2789.Unique Device Identifier (UDI)The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.How do I recognize a UDI on a label?AccessGUDID database - Identify Your Medical DeviceBenefits of a UDI SystemHow do I report a problem?Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.