Device product
VentStar Basic (P) 250, Catalog Number MP00352 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. Breathing Circuits/Anesthesia Sets with Water trap: Breathing circuit for conveying breathing gases between an anesthesia delivery system or ventilator and a pediatric patient. Intended for single use only. Water traps are intended for collection of condensate. The standard breathing circuit is equipped with a water trap in each breathing hose limb.
Z-0739-2019
Product summary
- Event
- Event 81874
- Status
- Terminated
- Classification
- Class I
- Quantity
- 75 units
- Official record key
device-enforcement:Z-0739-2019
Official wording
Reason: Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit
Code information: All Lots
Distribution pattern: US Distribution to states of: AL, CA, CO, CT, FL, KY, MI, NJ, OH, PA, SC & TX.
Derived failure modes
-
Unknown
Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit