DRAEGER MEDICAL INC

APOLLO · Anesthesiology

510(k): 0 Recall: 2 UDI: 0 MAUDE: 4 Class.: 59

Recalls (2)

Apollo Anesthesia Machine; Cat. no. 8605310 Product Usage: Indicated as a continuous flow anesthesia system. The Apollo may be used for manually assisted or automatic ventilation, delivery of gases and anesthetic vapor, and monitoring of oxygen and CO2 concentration, breathing pressure, respiratory

2018-05-24

The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC module would not prevent setting an N2O flow that would result in a hypoxic mixture from being dosed to the patient. Potential adverse outcomes include death of the patient.

Draeger Medical Apollo Anesthesia Machine, catalog number 8606500

2008-08-22

Sporadic errors in various device functions, including low readings of the single gas flows for oxygen, nitrous oxide, or air delivery, or mechanical ventilation failure. Alarms and error messages function as designed.

MAUDE Adverse Events (4)

Malfunction

20150821

Malfunction

20140512

Malfunction

20051216

Malfunction

20051212

FDA Classification (59)

Ventilator, Continuous, Minimal Ventilatory Support, Home Use

Anesthesiology

Humidifier, Respiratory Gas, (Direct Patient Interface)

Anesthesiology

Anesthesia Conduction Kit

Anesthesiology

Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia

Anesthesiology

High Flow/High Velocity Humidified Oxygen Delivery Device

Anesthesiology

Monitor, Carbon-Dioxide, Cutaneous

Anesthesiology

Plethysmograph, Pressure

Anesthesiology

Caudal Anesthesia Kit

Anesthesiology

Regulator, Pressure, Gas Cylinder

Anesthesiology

Bag, Reservoir

Anesthesiology

Brush, Cleaning, Tracheal Tube

Anesthesiology

Analyzer, Nitrogen Dioxide

Anesthesiology

Algesimeter, Powered

Anesthesiology

Ventilatory Effort Recorder

Anesthesiology

Adjunctive Pain Measurement Device For Anesthesiology

Anesthesiology

Rhinoanemometer (Measurement Of Nasal Decongestion)

Anesthesiology

Cabinet, Table And Tray, Anesthesia

Anesthesiology

Spreader, Cuff

Anesthesiology

Stethoscope, Esophageal

Anesthesiology

Oral Airway Assist

Anesthesiology

Spirometer, Diagnostic

Anesthesiology

Device, Positive Pressure Breathing, Intermittent

Anesthesiology

Sparse Sample Pk Profile And Dosing Software

Anesthesiology

Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)

Anesthesiology

Airway, Oropharyngeal, Anesthesiology

Anesthesiology

Airway, Nasopharyngeal

Anesthesiology

Device Indicating An Exhalation Event

Anesthesiology

Spacer, Direct Patient Interface

Anesthesiology

Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

Anesthesiology

Apparatus, Gas-Scavenging

Anesthesiology

Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase

Anesthesiology

Circulator, Breathing-Circuit

Anesthesiology

Percussor, Powered-Electric

Anesthesiology

Laryngoscope, Rigid

Anesthesiology

Blood Specimen Collection Kit (Excludes Hiv Testing)

Anesthesiology

Catheter, Nasal, Oxygen

Anesthesiology

Stimulator, Nerve, Ac-Powered

Anesthesiology

Valve, Switching (Ploss)

Anesthesiology

Stool, Anesthesia

Anesthesiology

Analyzer, Gas, Nitrogen, Gaseous-Phase

Anesthesiology

Stimulator, Nerve, Battery-Powered

Anesthesiology

Mask, Oxygen, Non-Rebreathing

Anesthesiology

Vaporizer, Anesthesia, Non-Heated

Anesthesiology

Analyzer, Gas, Neon, Gaseous-Phase

Anesthesiology

Cardiopulmonary Resuscitation Aid Kit

Anesthesiology

Catheters, Suction, Tracheobronchial

Anesthesiology

Spinal Anesthesia Kit

Anesthesiology

Analyzer, Nitrogen Dioxide, Exempt

Anesthesiology

Calibrator, Pressure, Gas

Anesthesiology

Needle, Conduction, Anesthetic (W/Wo Introducer)

Anesthesiology

Protector, Dental

Anesthesiology

Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)

Anesthesiology

Valve, Non-Rebreathing

Anesthesiology

Monitor, Breathing Frequency

Anesthesiology

Hood, Oxygen, Infant

Anesthesiology

Medevac Use Oxygen Generator

Anesthesiology

Support, Patient Position

Anesthesiology

Strap, Head, Gas Mask

Anesthesiology

Tube, Tracheostomy (W/Wo Connector)

Anesthesiology