Device product

VentStar Coax (P) 150, MP00379

Z-1451-2023

April 17, 2023

Class I

Product summary

Firm: Draeger Medical, Inc.
Event: Event 92049
Status: Terminated
Classification: Class I
Quantity: 280 units
Official record key: device-enforcement:Z-1451-2023

Official wording

Reason: Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

Code information: UDI-DI: 04048675421917; All lots.

Distribution pattern: Domestic: US Nationwide Distribution.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.