TPLC - Total Product Life Cycle

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Device	ventilator, emergency, powered (resuscitator)
Regulation Description	Powered emergency ventilator.
Product Code	BTL
Regulation Number	868.5925
Device Class	2

Premarket Reviews
Manufacturer	Decision
DRAEGERWERK AG & CO KGAA
	SUBSTANTIALLY EQUIVALENT	1
MAGNAMED TECNOLOGIA MEDICA S/A
	SUBSTANTIALLY EQUIVALENT	1
1. K221634 Oxymag - Transport and Emergency Ventilator
VORTRAN MEDICAL TECHNOLOGY 1, INC.
	SUBSTANTIALLY EQUIVALENT	1
WEINMANN EMERGENCY MEDICAL TECHNOLOGY GMBH + CO. KG
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Pressure Problem	665	666
Break	555	556
Device Alarm System	241	241
Failure to Cycle	204	204
Gas/Air Leak	152	152
Mechanical Problem	126	126
Loose or Intermittent Connection	104	104
Tidal Volume Fluctuations	102	102
Defective Component	96	96
Detachment of Device or Device Component	84	84
Defective Device	75	77
No Audible Alarm	68	68
Component Missing	67	67
Defective Alarm	61	62
Battery Problem	57	57
Incorrect, Inadequate or Imprecise Result or Readings	55	55
Crack	54	54
Fracture	53	53
Inaccurate Delivery	48	48
Noise, Audible	47	47
Leak/Splash	44	44
Insufficient Information	40	40
Output Problem	40	40
Power Problem	38	38
Connection Problem	36	36
Failure to Power Up	35	35
Calibration Problem	35	35
Improper Flow or Infusion	33	33
Increase in Pressure	30	30
Decrease in Pressure	29	29
Unable to Obtain Readings	28	28
Key or Button Unresponsive/not Working	28	28
Failure to Deliver	28	28
Infusion or Flow Problem	27	27
Gas Output Problem	26	26
No Flow	26	26
Display or Visual Feedback Problem	25	25
Device Fell	25	25
Volume Accuracy Problem	23	23
Inaccurate Flow Rate	22	22
Free or Unrestricted Flow	20	20
Device Sensing Problem	20	20
Therapeutic or Diagnostic Output Failure	20	20
Electrical /Electronic Property Problem	19	19
Device Difficult to Maintain	19	19
Disconnection	19	19
No Pressure	18	18
Device Damaged Prior to Use	17	17
Physical Resistance/Sticking	16	16
Failure of Device to Self-Test	14	14

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2459	2462
Insufficient Information	558	560
No Information	181	181
No Patient Involvement	164	164
No Consequences Or Impact To Patient	90	90
No Known Impact Or Consequence To Patient	44	44
Low Oxygen Saturation	12	12
Hypoventilation	7	7
Cardiac Arrest	6	6
Hypoxia	5	5
Pneumothorax	4	4
Respiratory Arrest	4	4
Bradycardia	3	3
Decreased Respiratory Rate	3	3
Respiratory Insufficiency	2	2
Ventilator Dependent	2	2
Respiratory Failure	2	2
Patient Problem/Medical Problem	1	1
Air Embolism	1	1
Sleep Dysfunction	1	1
Cyanosis	1	1
Pulmonary Hypertension	1	1
Apnea	1	1
Respiratory Distress	1	1
Sepsis	1	1
Ischemia	1	1
Pleural Empyema	1	1
Asthma	1	1
Low Cardiac Output	1	1
Unspecified Blood or Lymphatic problem	1	1
Overinflation of Lung	1	1
Unspecified Respiratory Problem	1	1
Hyperventilation	1	1
Respiratory Distress Syndrome of Newborns	1	1
Airway Obstruction	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Mercury Enterprises, Inc. dba Mercury Medical	I	Jan-10-2025
2	Mercury Enterprises, Inc. dba Mercury Medical	I	Oct-02-2024
3	Precision Valve & Automation,Inc	II	Aug-14-2020
4	Smiths Medical ASD Inc.	I	Sep-20-2024
5	Smiths Medical ASD Inc.	I	Sep-11-2024
6	Smiths Medical ASD Inc.	I	Mar-19-2024
7	Smiths Medical ASD Inc.	III	Oct-22-2021