Device product
MAQUET Servo Humidifier 163; Model No.: 01-06-8125-8, catalog no. XKC01-06-8125-8. A heat and moisture condenser (artificial nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to warm and humidify gases breathed in by a patient.
Z-1008-2015
Product summary
- Firm
- Teleflex, Inc.
- Event
- Event 70127
- Status
- Terminated
- Classification
- Class I
- Quantity
- 18
- Official record key
device-enforcement:Z-1008-2015
Official wording
Reason: Connector mount cracks which may lead to a leak failure during use and necessitate immediate replacement in the breathing circuit. If leak exists and is left untreated, patient may be deprived of adequate anesthetic gases over a period of time and serious adverse health consequences may occur.
Code information: Batch Numbers: 201321, 201323, and 201324.
Distribution pattern: Distributed in the states of FL, MI, WV, and KS.
Derived failure modes
-
Unknown
Connector mount cracks which may lead to a leak failure during use and necessitate immediate replacement in the breathing circuit. If leak exists and is left untreated, patient may be deprived of adequate anesthetic gases over a period of time and serious adverse health consequences may occur.