TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
ATOM MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
BISTOS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
DATEX OHMEDA INC.
	SUBSTANTIALLY EQUIVALENT	1
DRAEGER MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
DRAEGER MEDICAL SYTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
DRAEGERWERK AG & CO. KGAA
	SUBSTANTIALLY EQUIVALENT	1
DRAGERWERK AG & CO. KGAA
	SUBSTANTIALLY EQUIVALENT	1
NINGBO DAVID MEDICAL DEVICE CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
OHMEDA MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
OHMEDA MEDICAL, A DIVISION OF DATEX-OHMEDA, INC.
	SUBSTANTIALLY EQUIVALENT	1
OHMEDA MEDICAL, A DIVISION OF DATEX-OHMEDA,INC. A GE COMPANY
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	22	22
Insufficient Flow or Under Infusion	16	16
Microbial Contamination of Device	11	11
Appropriate Term/Code Not Available	10	10
Mechanical Problem	9	9
Contamination /Decontamination Problem	7	7
Device Operates Differently Than Expected	6	6
Insufficient Information	6	6
Contamination	6	6
Device Displays Incorrect Message	6	6
Break	6	6
Excessive Heating	5	5
Gas/Air Leak	4	4
Therapeutic or Diagnostic Output Failure	4	4
Fire	4	4
Calibration Problem	4	4
Temperature Problem	4	4
Insufficient Heating	4	4
Device Emits Odor	4	4
Failure to Calibrate	3	3
Crack	3	3
Loose or Intermittent Connection	3	3
Battery Problem	3	3
Output Problem	2	2
Unexpected Therapeutic Results	2	2
Fluid/Blood Leak	2	2
Charging Problem	2	2
Device Alarm System	2	2
Structural Problem	2	2
Kinked	2	2
Overheating of Device	2	2
Smoking	2	2
Display or Visual Feedback Problem	2	2
Positioning Problem	2	2
Use of Device Problem	2	2
No Flow	2	2
Power Problem	2	2
Detachment Of Device Component	1	1
Loss of or Failure to Bond	1	1
Difficult to Open or Close	1	1
Component Falling	1	1
Disconnection	1	1
Sparking	1	1
Unexpected Shutdown	1	1
Device Slipped	1	1
Moisture Damage	1	1
Key or Button Unresponsive/not Working	1	1
Failure to Deliver	1	1
Output above Specifications	1	1
Patient Device Interaction Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	71	71
No Known Impact Or Consequence To Patient	18	18
Fall	14	14
Insufficient Information	12	12
No Information	11	11
No Patient Involvement	11	11
Skull Fracture	8	8
Hematoma	8	8
Death	7	7
Bacterial Infection	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Head Injury	3	3
Alteration In Body Temperature	3	3
No Consequences Or Impact To Patient	3	3
Sepsis	2	2
Fungal Infection	2	2
Burn, Thermal	2	2
Injury	2	2
Burn(s)	2	2
Alteration in Body Temperature	2	2
Hypothermia	2	2
Hyperthermia	2	2
Low Blood Pressure/ Hypotension	2	2
Emotional Changes	1	1
Bone Fracture(s)	1	1
Cardiac Arrest	1	1
Rash	1	1
Hypernatremia	1	1
Pain	1	1
Bradycardia	1	1
Limb Fracture	1	1
Skin Tears	1	1
Irritability	1	1
Tissue Breakdown	1	1
Low Oxygen Saturation	1	1
Bruise/Contusion	1	1
Distress	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Atom Medical Corporation	II	Jul-06-2012
2	Atom Medical Corporation	II	Dec-01-2011
3	CooperSurgical, Inc.	II	Aug-16-2021
4	DATEX--OHMEDA, INC.	II	Jul-06-2023
5	GE Healthcare, LLC	II	Jun-15-2020
6	GE Healthcare, LLC	II	May-22-2020
7	GE Healthcare, LLC	II	Nov-04-2019
8	GE Healthcare, LLC	II	Nov-19-2018
9	GE Healthcare, LLC	I	Apr-05-2013
10	Maquet Datascope Corp - Cardiac Assist Division	I	Jun-13-2011
11	Natus Medical Incorporated	II	Oct-07-2016
12	Natus Medical Incorporated	II	Apr-11-2016
13	Ohmeda Medical	II	Oct-04-2019
14	Ohmeda Medical	II	Mar-20-2017
15	Wipro GE Healthcare Private Ltd.	I	Feb-09-2024