Condenser, Heat And Moisture (Artificial Nose)

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2024-10-23Open, ClassifiedPackaging process control

  smiths medical portex, Y' PIECE 15MM, REF 100/276/000

  Uncertainty in the seal integrity of the sterile packaging.

• 2024-10-23Open, ClassifiedPackaging process control

  smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000

  Uncertainty in the seal integrity of the sterile packaging.

• 2024-10-23Open, ClassifiedPackaging process control

  smiths medical portex, Thermovent 1200, 15mm/22mm: a) REF 100/582/000; b) REF 100/582/000JP; c) REF 100/582/000JS

  Uncertainty in the seal integrity of the sterile packaging.

• 2016-08-29TerminatedDevice Design

  MAQUET Servo Humidifier 163, Inmed Mfg. Sdn. Bhd. Lot PT 2577, Jalan Perusahaan, 4, 34600 Kamunting, Perak, Malaysia.

  Cracking may occur at the 15mm and 22mm ISO female connector.

• 2016-08-09TerminatedRelease of Material/Component prior to receiving test results

  Servo Humidifier 163, Model 01-06-8125-8, REF 6419365 Product Usage: A heat and moisture condenser (artifical 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 humidity gases breathed in by the patient.

  Cracks may occur at the 15mm and 22mm ISO female connector.

• 2015-05-09TerminatedProcess control

  ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathing circuit.

  Outer shipping carton was marked with an incorrect expiry date, however inner product carton was labeled correctly.

• 2015-02-06TerminatedProcess control

  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.

  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.

• 2015-02-06TerminatedProcess control

  MAQUET, SERVO Humidifier 163, Rx Only, Inmed Mfg. Sdn Bhd. Catalog No: XKC01-06-8125-8, Model No. 01-06-8125-8. 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.

  Defects: Cracks that may occur in the center of the corrugated flex tube of the 15 mm and 22 mm ISO female connector.

• 2011-07-30TerminatedDevice Design

  Vital Signs- A GE Healthcare Company - Hygroscopic Condenser Humidifier (HCH)/Anesthesia Breathing Circuit; GE Medical Systems SCS 283 rue de la Miniere 78530 BUC, France p +33.1.30.70.40.40; Vital Signs Colorado Inc 11039 E. Lansing Circle Englewood, CO 80112 P +1.973.956.5300. The intended use of the device is to provide proper flow of the medical gases or oxygen to patients under anesthesia or ventilation.

  The Hygroscopic Condenser Humidifier (HCH) device may have an occlusion that can prevent proper flow of the medical gases or oxygen, possibly resulting in insufficient oxygen delivered to the patient.

• 2004-07-22TerminatedOther

  Portex Thermovent T, Heat and Moisture Exchangers Catalog # 570016;

  Sterility of the device is compromised due to lack of package integrity