TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
ATOM MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
DATEX OHMEDA INC.
	SUBSTANTIALLY EQUIVALENT	1
DEROYAL INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	2
DRAEGER MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	2
GE HEALTHCARE
	SUBSTANTIALLY EQUIVALENT	1
INTERNATIONAL BIOMEDICAL
	SUBSTANTIALLY EQUIVALENT	1
OHMEDA MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
OHMEDA MEDICAL, A DIVISION OF DATEX-OHMEDA, INC.,
	SUBSTANTIALLY EQUIVALENT	2
WIPRO GE HEALTHCARE PRIVATE, LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Integrity Problem	3343	3417
Crack	221	221
Break	176	176
Device Alarm System	54	54
Electrical /Electronic Property Problem	46	46
Material Discolored	39	39
No Audible Alarm	38	38
Nonstandard Device	34	34
Output Problem	29	29
Device Displays Incorrect Message	29	29
Device Issue	27	27
Incorrect, Inadequate or Imprecise Result or Readings	26	26
Mechanical Problem	21	21
Fracture	18	18
Insufficient Flow or Under Infusion	18	18
Detachment of Device or Device Component	16	16
Gas/Air Leak	15	15
Device Operates Differently Than Expected	15	15
Therapeutic or Diagnostic Output Failure	12	12
Microbial Contamination of Device	11	11
Defective Alarm	11	11
Overheating of Device	10	10
Device Sensing Problem	9	9
Product Quality Problem	9	9
Adverse Event Without Identified Device or Use Problem	9	9
Thermal Decomposition of Device	9	9
Temperature Problem	9	9
Protective Measures Problem	8	9
Contamination	8	8
Melted	7	7
Device Damaged Prior to Use	7	7
Smoking	7	7
Appropriate Term/Code Not Available	6	6
Unable to Obtain Readings	6	6
Device Handling Problem	5	5
Failure To Adhere Or Bond	5	5
Use of Device Problem	5	5
Mechanics Altered	4	4
Loose or Intermittent Connection	4	4
Low Readings	4	4
No Apparent Adverse Event	4	4
Fire	4	4
Loss of or Failure to Bond	4	4
Device Fell	4	4
Device Dislodged or Dislocated	3	3
Improper or Incorrect Procedure or Method	3	3
Excessive Heating	3	3
Display or Visual Feedback Problem	3	3
Loss of Power	3	3
Device Inoperable	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Patient Involvement	2689	2764
No Clinical Signs, Symptoms or Conditions	869	869
Insufficient Information	324	324
No Known Impact Or Consequence To Patient	182	182
No Consequences Or Impact To Patient	65	65
Fall	12	12
Alteration in Body Temperature	10	10
No Information	8	8
Skull Fracture	7	7
Burn(s)	6	6
No Code Available	5	5
Hypothermia	4	4
Low Oxygen Saturation	3	3
Superficial (First Degree) Burn	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Inadequate Osseointegration	2	2
Not Applicable	2	2
Injury	2	2
Death	1	1
Complaint, Ill-Defined	1	1
Fungal Infection	1	1
Bone Fracture(s)	1	1
Hematoma	1	1
Abrasion	1	1
Edema	1	1
Skin Discoloration	1	1
Alteration In Body Temperature	1	1
Fever	1	1
Swelling	1	1
Bradycardia	1	1
Hyperthermia	1	1
Tachycardia	1	1
Hypoxia	1	1
Tissue Damage	1	1
Partial thickness (Second Degree) Burn	1	1
Hemorrhage/Bleeding	1	1
Thromboembolism	1	1
Full thickness (Third Degree) Burn	1	1
Bruise/Contusion	1	1
External Prosthetic Device Pain	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	DeRoyal Industries Inc	II	Nov-30-2015
2	Draeger Medical Systems, Inc.	II	Jun-22-2023
3	Draeger Medical Systems, Inc.	II	Aug-26-2009
4	Draeger Medical Systems, Inc.	I	Aug-25-2009
5	Draeger Medical, Inc.	II	Jul-28-2016
6	Fisher & Paykel Healthcare, Ltd.	II	Nov-13-2014
7	GE Healthcare	II	May-06-2014
8	GE Healthcare	II	Feb-03-2014
9	GE Healthcare, LLC	I	Dec-03-2019
10	GE Healthcare, LLC	I	Jul-11-2019
11	GE Healthcare, LLC	II	Nov-19-2018
12	GE Healthcare, LLC	II	May-19-2017
13	GE Healthcare, LLC	II	Jan-11-2017
14	Ohmeda Medical	II	Mar-20-2017