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
VORTRAN MEDICAL TECHNOLOGY 1, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Pressure Problem	563	564
Break	381	382
Failure to Cycle	181	181
Device Alarm System	178	178
Gas/Air Leak	151	151
Mechanical Problem	109	109
Loose or Intermittent Connection	95	95
Detachment of Device or Device Component	95	95
Tidal Volume Fluctuations	86	86
Defective Component	62	62
Defective Alarm	57	58
Component Missing	56	56
Defective Device	54	54
Battery Problem	51	51
Fracture	50	50
Inaccurate Delivery	48	48
Incorrect, Inadequate or Imprecise Result or Readings	46	46
No Audible Alarm	44	44
Noise, Audible	43	43
Crack	40	40
Insufficient Device Problem Information	38	38
Leak/Splash	32	32
Connection Problem	30	30
Calibration Problem	29	29
Unable to Obtain Readings	28	28
Power Problem	27	27
Failure to Power Up	26	26
Failure to Deliver	26	26
Decrease in Pressure	26	26
Key or Button Unresponsive/not Working	26	26
Improper Flow or Infusion	25	25
Display or Visual Feedback Problem	24	24
Gas Output Problem	22	22
Volume Accuracy Problem	22	22
Inaccurate Flow Rate	21	21
Free or Unrestricted Flow	19	19
Device Difficult to Maintain	19	19
Device Fell	19	19
Increase in Pressure	19	19
Infusion or Flow Problem	18	18
Device Sensing Problem	18	18
Disconnection	17	17
No Flow	16	16
Electrical /Electronic Property Problem	16	16
No Pressure	14	14
Device Damaged Prior to Use	14	14
Insufficient Flow or Under Infusion	13	13
Loss of or Failure to Bond	12	12
Failure of Device to Self-Test	12	12
Fluid/Blood Leak	12	12

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2440	2443
Insufficient Information	558	560
No Information	28	28
No Patient Involvement	19	19
Low Oxygen Saturation	11	11
Hypoventilation	7	7
Respiratory Arrest	4	4
Cardiac Arrest	4	4
No Consequences Or Impact To Patient	4	4
Hypoxia	4	4
Pneumothorax	4	4
Bradycardia	3	3
Decreased Respiratory Rate	3	3
Respiratory Failure	2	2
Respiratory Insufficiency	2	2
Cyanosis	1	1
Low Cardiac Output	1	1
Hyperventilation	1	1
Apnea	1	1
Pleural Empyema	1	1
Intraoperative Cardiac Valve Injury	1	1
Sepsis	1	1
Pulmonary Hypertension	1	1
Respiratory Distress Syndrome of Newborns	1	1
Unspecified Blood or Lymphatic problem	1	1
Ischemia	1	1
Sleep Dysfunction	1	1
Unspecified Respiratory Problem	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	Smiths Medical ASD Inc.	I	Sep-20-2024
4	Smiths Medical ASD Inc.	I	Sep-11-2024
5	Smiths Medical ASD Inc.	I	Mar-19-2024
6	Smiths Medical ASD Inc.	III	Oct-22-2021