TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
DATEX OHMEDA INC.
	SUBSTANTIALLY EQUIVALENT	1
DRAGERWERK AG & CO. KGAA
	SUBSTANTIALLY EQUIVALENT	1
NINGBO DAVID MEDICAL DEVICE CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	14	14
Microbial Contamination of Device	10	10
Appropriate Term/Code Not Available	8	8
Contamination /Decontamination Problem	7	7
Mechanical Problem	7	7
Excessive Heating	5	5
Temperature Problem	4	4
Break	4	4
Insufficient Heating	4	4
Insufficient Flow or Under Infusion	4	4
Crack	3	3
Therapeutic or Diagnostic Output Failure	3	3
Insufficient Information	3	3
Calibration Problem	3	3
Gas/Air Leak	2	2
Output Problem	2	2
Display or Visual Feedback Problem	2	2
Unexpected Therapeutic Results	2	2
Loose or Intermittent Connection	2	2
Device Alarm System	2	2
Fluid/Blood Leak	2	2
Failure to Calibrate	2	2
Structural Problem	2	2
Decreased Sensitivity	1	1
Sparking	1	1
Battery Problem	1	1
Failure to Deliver	1	1
Inaccurate Delivery	1	1
Failure to Infuse	1	1
Incorrect Measurement	1	1
Use of Device Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Defective Component	1	1
Unintended Ejection	1	1
Fire	1	1
Thermal Decomposition of Device	1	1
Use of Incorrect Control/Treatment Settings	1	1
Corroded	1	1
Moisture Damage	1	1
Nonstandard Device	1	1
Device Emits Odor	1	1
Overheating of Device	1	1
Self-Activation or Keying	1	1
Device Slipped	1	1
Smoking	1	1
Power Problem	1	1
Protective Measures Problem	1	1
Device Sensing Problem	1	1
Device Dislodged or Dislocated	1	1
Electrical Shorting	1	1
Device Contamination with Chemical or Other Material	1	1
Material Integrity Problem	1	1
No Flow	1	1
Device Handling Problem	1	1
Unintended Electrical Shock	1	1
Unexpected Shutdown	1	1
Fail-Safe Did Not Operate	1	1
Key or Button Unresponsive/not Working	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	52	52
Fall	12	12
Insufficient Information	11	11
No Patient Involvement	9	9
Skull Fracture	8	8
Death	5	5
Hematoma	5	5
No Known Impact Or Consequence To Patient	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Burn(s)	2	2
Alteration in Body Temperature	2	2
Hyperthermia	2	2
Hypothermia	2	2
No Consequences Or Impact To Patient	2	2
Alteration In Body Temperature	2	2
Head Injury	2	2
Hypernatremia	1	1
Distress	1	1
Injury	1	1
Irritability	1	1
Low Oxygen Saturation	1	1
Pain	1	1
Sepsis	1	1
Emotional Changes	1	1
Bradycardia	1	1
Bruise/Contusion	1	1
Limb Fracture	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	CooperSurgical, Inc.	II	Aug-16-2021
2	DATEX--OHMEDA, INC.	II	Jul-06-2023
3	GE Healthcare, LLC	II	Jun-15-2020
4	GE Healthcare, LLC	II	May-22-2020
5	GE Healthcare, LLC	II	Nov-04-2019
6	Ohmeda Medical	II	Oct-04-2019
7	Wipro GE Healthcare Private Ltd.	I	Feb-09-2024