This article deals with FDA device approval which Recalls Draeger Medical’s Seattle PAP Plus and Breathing Circuit/Anesthesia Kits due to the risk of loose or detached components restricting breathing support. The use of these devices can result in significant injury or death. The FDA device approval products that have been recalled are – Seattle PAP Plus, VentStar Basic (P)180, VentStar Basic(P)250, VentStar Watertrap (P) 180, VentStar Watertrap (P) 180 w/oLL, VentStar Anesthesia WT (P)180, a few more. See Recall Database Entry
Draeger Medical Seattle-Positive Airway Pressure (PAP)
The Draeger Medical Seattle-Positive Airway Pressure (PAP) Plus device is designed to deliver Bubble continuous positive airway pressure (CPAP) treatment to newborns in the hospital who are struggling to breathe in respiratory distress. Breathing circuits and anesthesia kits are used to support breathing.
Due to a manufacturing defect, Draeger Medical is recalling the VentStar, Seattle PAP Plus, and other breathing circuits/anesthesia kits. This is because bonded connections may become free before or during ventilation. Components like the water trap, y-piece, or hose connector may partially or totally separate as a result. These components can become loose or come loose, interrupting the breathing circuit and perhaps leading to hypoxia (loss of oxygen) or even death. Patients who are severely unwell, including newborns (neonates), have a particularly high risk of suffering harm or passing away. There have been no reported injuries or fatalities, according to Draeger Medical.
Who Could Be Affected
- The Seattle PAP Plus, ventilators employ the impacted breathing circuit, or anesthetic kits that assist infants, toddlers, or adults.
- Healthcare providers provide care for patients with Seattle PAP Plus ventilators.
What should you do?
Draeger sent an urgent medical device recall letter to affected customers.
- Refrain from using the affected items.
- Examine the present inventory and quarantine or separate any unused items to keep them from being used.
- Implement alternative treatment as soon as you can. Nasal continuous positive airway pressure (nCPAP), noninvasive positive pressure ventilation (NIPPV), high flow nasal canula, and invasive mechanical ventilation (as a last resort) are examples of alternative therapy.
- Don’t depend on your decision to quit using the system on any device output, such as oxygen desaturation.
- Make sure that everyone in the organization, including product users, is informed of the urgent medical device recall.
Report the issue
Medical professionals and consumers can use the online form or call 1-800-332-1088 for further information on mailing or faxing the form to MedWatch: The FDA Safety Information and Adverse Event Reporting Program to report adverse reactions or quality issues they encountered while using these devices.
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Source: FDA Recall
