Device product
ErgoStar CM 55, Model/Catalog Number: MP01855, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient.
Z-0592-2026
Product summary
- Firm
- Draeger, Inc.
- Event
- Event 97923
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 118850 units
- Official record key
device-enforcement:Z-0592-2026
Official wording
Reason: Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
Code information: Model/Catalog Number: MP01855; UDI Number: 04048675420705; Lot numbers: All lot numbers;
Distribution pattern: Worldwide distribution. US states of CA, FL, IL, NY, OH, OK, PA, SC, TX, and WI; Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, Ecuador, Finland, France, Germany, Hungary, Indonesia, Italy, Japan, Mexico, Netherlands, Norway, Pakistan, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, South Africa, South Korea, Spain, Switzerland, Thailand, Turkiye, Ukraine, and United Kingdom.
Derived failure modes
-
Unknown
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.