TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
ALLIED HEALTHCARE PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	5
ATOM MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
AUTOMEDX INC.
	SUBSTANTIALLY EQUIVALENT	1
DOLPHYS MEDICAL B.V.
	SUBSTANTIALLY EQUIVALENT	1
INTERNATIONAL BIOMEDICAL
	SUBSTANTIALLY EQUIVALENT	2
MAGNAMED TECNOLOGIA MEDICA S/A
	SUBSTANTIALLY EQUIVALENT	1
MERCURY MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
MERCURY MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
NEOFORCE GROUP, INC.
	SUBSTANTIALLY EQUIVALENT	1
O-TWO MEDICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	3
SMITHS MEDICAL INTERNATIONAL LTD.
	SUBSTANTIALLY EQUIVALENT	1
THORNHILL RESEARCH INC
	SUBSTANTIALLY EQUIVALENT	2
THORNHILL RESEARCH INC.
	SUBSTANTIALLY EQUIVALENT	1
VBM MEDIZINTECHNIK GMBH
	SUBSTANTIALLY EQUIVALENT	1
VENTLAB, LLC
	SUBSTANTIALLY EQUIVALENT	1
VORTRAN MEDICAL TECHNOLOGY 1, INC.
	SUBSTANTIALLY EQUIVALENT	2
WEINMANN EMERGENCY MEDICAL TECHNOLOGY GMBH + CO. KG
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	791	791
Pressure Problem	736	736
Device Alarm System	275	275
Failure to Cycle	210	210
Tidal Volume Fluctuations	143	143
Mechanical Problem	139	139
Defective Component	125	125
Gas/Air Leak	124	124
Loose or Intermittent Connection	97	97
Component Missing	95	95
No Audible Alarm	83	83
Detachment of Device or Device Component	82	82
Defective Device	78	78
Device Issue	75	75
Output Problem	73	73
Defective Alarm	73	73
Battery Problem	70	70
Noise, Audible	68	68
Crack	68	68
Incorrect, Inadequate or Imprecise Result or Readings	60	60
Fracture	54	54
Leak/Splash	51	51
Infusion or Flow Problem	48	48
Power Problem	46	46
Connection Problem	43	43
Failure to Power Up	40	40
Device Operates Differently Than Expected	38	38
Calibration Problem	37	37
Insufficient Information	36	36
Increase in Pressure	35	35
Failure to Deliver	34	34
Decrease in Pressure	33	33
Improper Flow or Infusion	32	32
Device Handling Problem	32	32
Unable to Obtain Readings	31	31
Device Fell	29	29
No Flow	28	28
Display or Visual Feedback Problem	27	27
Key or Button Unresponsive/not Working	27	27
Physical Resistance/Sticking	27	27
Gas Output Problem	26	26
Electrical /Electronic Property Problem	25	25
Therapeutic or Diagnostic Output Failure	25	25
Device Damaged Prior to Use	21	21
Volume Accuracy Problem	20	20
No Pressure	19	19
Device Difficult to Maintain	19	19
Disconnection	19	19
Device Sensing Problem	18	18
Inaccurate Flow Rate	18	18

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2200	2200
Insufficient Information	546	546
No Patient Involvement	421	421
No Known Impact Or Consequence To Patient	392	392
No Information	276	276
No Consequences Or Impact To Patient	215	215
Low Oxygen Saturation	24	24
Hypoventilation	11	11
Death	10	10
Patient Problem/Medical Problem	9	9
Cardiac Arrest	9	9
Apnea	6	6
Not Applicable	6	6
Hypoxia	6	6
Pneumothorax	4	4
Respiratory Distress	4	4
Respiratory Arrest	4	4
Bradycardia	4	4
Decreased Respiratory Rate	3	3
Low Blood Pressure/ Hypotension	3	3
Cardiopulmonary Arrest	3	3
Ventilator Dependent	2	2
Respiratory Failure	2	2
Complaint, Ill-Defined	2	2
Respiratory Insufficiency	2	2
Respiratory Distress Syndrome of Newborns	2	2
Hyperventilation	2	2
Asphyxia	2	2
Distress	1	1
Airway Obstruction	1	1
Inadequate Pain Relief	1	1
Bacterial Infection	1	1
Unspecified Respiratory Problem	1	1
Anxiety	1	1
Missing Value Reason	1	1
Overinflation of Lung	1	1
Respiratory Tract Infection	1	1
Loss Of Pulse	1	1
Paralysis	1	1
Unspecified Blood or Lymphatic problem	1	1
Respiratory Acidosis	1	1
Chronic Obstructive Pulmonary Disease (COPD)	1	1
Low Cardiac Output	1	1
Asthma	1	1
Resuscitation	1	1
Pleural Empyema	1	1
Ischemia	1	1
Diminished Pulse Pressure	1	1
Sepsis	1	1
No Code Available	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Draeger Medical Systems, Inc.	I	Apr-10-2014
2	GE Healthcare	II	Feb-03-2014
3	GE Healthcare, LLC	I	Feb-25-2014
4	GE Healthcare, LLC	I	Feb-08-2013
5	GE Healthcare, LLC	I	Dec-26-2012
6	Impact Instrumentation, Inc.	II	Jun-26-2015
7	Instrumentation Industries Inc	II	Apr-16-2013
8	Mercury Enterprises, Inc. dba Mercury Medical	II	Jan-12-2016
9	O-Two Medical Technologies, Inc.	I	Apr-04-2019
10	Precision Valve & Automation,Inc	II	Aug-14-2020
11	Smiths Medical ASD Inc.	I	Sep-20-2024
12	Smiths Medical ASD Inc.	I	Sep-11-2024
13	Smiths Medical ASD Inc.	I	Mar-19-2024
14	Smiths Medical ASD Inc.	III	Oct-22-2021
15	Thornhill Research Inc	I	Jan-11-2016
16	Vortran Medical Technology 1, Inc	II	Apr-25-2017