TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
DATEX-OHMEDA, INC.
	SUBSTANTIALLY EQUIVALENT	1
DRÄGERWERK AG CO. KGAA
	SUBSTANTIALLY EQUIVALENT	1
MAQUET CRITICAL CARE AB
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Therapeutic or Diagnostic Output Failure	4861	4861
Mechanical Problem	2850	2850
Failure to Run on Battery	2552	2552
No Display/Image	1578	1578
Insufficient Flow or Under Infusion	1188	1188
Failure to Deliver	859	859
Gas/Air Leak	818	818
Unexpected Therapeutic Results	793	793
Output Problem	727	727
Power Problem	700	700
Gas Output Problem	699	699
Increase in Pressure	651	651
Unexpected Shutdown	650	650
Electrical /Electronic Property Problem	459	459
Infusion or Flow Problem	394	394
Inaccurate Delivery	373	373
Failure to Power Up	285	285
Suction Failure	223	223
Physical Resistance/Sticking	208	208
Decrease in Suction	196	196
No Visual Prompts/Feedback	187	187
Intermittent Continuity	181	181
Pressure Problem	168	168
Inappropriate or Unexpected Reset	152	152
Break	147	147
Insufficient Information	138	138
No Audible Alarm	126	126
Intermittent Communication Failure	125	125
Detachment of Device or Device Component	124	124
Decrease in Pressure	116	116
Complete Loss of Power	105	105
Leak/Splash	74	74
Adverse Event Without Identified Device or Use Problem	63	63
No Apparent Adverse Event	62	62
Battery Problem	61	61
Protective Measures Problem	55	55
Display or Visual Feedback Problem	55	55
Use of Device Problem	54	54
Failure to Analyze Signal	52	52
No Pressure	51	51
No Flow	45	45
Device Displays Incorrect Message	35	35
Circuit Failure	34	34
Energy Output Problem	33	33
Failure to Sense	32	32
Computer Software Problem	29	29
Degraded	26	26
Calibration Problem	25	25
Improper Flow or Infusion	24	24
Excess Flow or Over-Infusion	23	23

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	19009	19009
No Patient Involvement	1166	1166
Insufficient Information	815	815
No Consequences Or Impact To Patient	632	632
Low Oxygen Saturation	91	91
No Known Impact Or Consequence To Patient	40	40
Cardiac Arrest	20	20
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	17	17
Awareness during Anaesthesia	12	12
Loss of consciousness	7	7
Vomiting	7	7
Hypoxia	6	6
Cyanosis	5	5
Bradycardia	5	5
Low Blood Pressure/ Hypotension	4	4
No Information	4	4
Oversedation	4	4
Death	3	3
Apnea	3	3
Respiratory Arrest	3	3
Brain Injury	3	3
Nausea	3	3
Unspecified Respiratory Problem	3	3
Capsular Contracture	3	3
Tachycardia	3	3
Airway Obstruction	2	2
Pneumothorax	2	2
Headache	2	2
Convulsion/Seizure	2	2
Cough	2	2
Cardiopulmonary Arrest	2	2
Lethargy	1	1
Respiratory Distress Syndrome of Newborns	1	1
Therapeutic Effects, Unexpected	1	1
Anxiety	1	1
Bronchospasm	1	1
Pulmonary Edema	1	1
Asystole	1	1
Laceration(s)	1	1
Coma	1	1
Overinflation of Lung	1	1
Dyspnea	1	1
Swelling	1	1
Chills	1	1
Unspecified Mental, Emotional or Behavioural Problem	1	1
Burn(s)	1	1
Pulmonary Insufficiency	1	1
Unspecified Blood or Lymphatic problem	1	1
Respiratory Acidosis	1	1
Cardiac Tamponade	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Datex-Ohmeda, Inc.	I	Oct-18-2024
2	Draeger Medical, Inc.	I	Dec-18-2024
3	Draeger Medical, Inc.	I	Nov-13-2024
4	Draeger Medical, Inc.	I	Apr-18-2024
5	Draeger Medical, Inc.	II	Jan-14-2022
6	Draegerwerk Ag & Co. Kgaa	II	Feb-01-2024
7	GE Healthcare, LLC	II	Jul-20-2022
8	GE Healthcare, LLC	I	Jul-19-2022
9	GE Healthcare, LLC	II	Jun-24-2022
10	GE Healthcare, LLC	II	Sep-30-2021
11	GE Healthcare, LLC	II	Oct-30-2020
12	GE Healthcare, LLC	I	Jan-23-2020
13	Getinge Group Logistics America, LLC	II	Mar-05-2021
14	Getinge Usa Sales Inc	I	May-31-2024
15	Getinge Usa Sales Inc	II	Feb-06-2024
16	Getinge Usa Sales Inc	I	Jan-26-2023
17	Getinge Usa Sales Inc	II	Dec-07-2022
18	Getinge Usa Sales Inc	I	Jun-23-2022
19	Getinge Usa Sales Inc	I	Jan-10-2022
20	Mindray DS USA, Inc. dba Mindray North America	II	Sep-04-2024