TPLC - Total Product Life Cycle

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Device	system, monitoring, perinatal
Product Code	HGM
Regulation Number	884.2740
Device Class	2

Premarket Reviews
Manufacturer	Decision
BLOOM TECHNOLOGIES NV
	SUBSTANTIALLY EQUIVALENT	1
DATEX OHMEDA
	SUBSTANTIALLY EQUIVALENT	1
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
HUNTLEIGH HEALTHCARE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
No Audible Prompt/Feedback	94	94
No Audible Alarm	91	91
Incorrect Measurement	29	29
High Test Results	29	29
Incorrect, Inadequate or Imprecise Result or Readings	28	28
Defective Alarm	25	25
High Readings	22	22
Material Integrity Problem	18	18
No Apparent Adverse Event	16	16
Insufficient Information	16	16
Adverse Event Without Identified Device or Use Problem	16	16
Device Alarm System	15	15
Unable to Obtain Readings	13	13
Appropriate Term/Code Not Available	8	8
Electrical /Electronic Property Problem	7	7
No Visual Prompts/Feedback	6	6
Crack	5	5
Audible Prompt/Feedback Problem	5	5
Circuit Failure	4	4
Overheating of Device	4	4
Erratic or Intermittent Display	4	4
Protective Measures Problem	3	3
Electrical Shorting	3	3
Use of Device Problem	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Failure to Sense	3	3
Failure to Transmit Record	3	3
Output Problem	3	3
Therapeutic or Diagnostic Output Failure	2	2
Patient Device Interaction Problem	2	2
No Device Output	2	2
Device Displays Incorrect Message	2	2
Erratic Results	2	2
Improper or Incorrect Procedure or Method	2	2
False Alarm	2	2
Signal Artifact/Noise	2	2
Operating System Becomes Nonfunctional	2	2
Inaudible or Unclear Audible Prompt/Feedback	2	2
Image Display Error/Artifact	2	2
Noise, Audible	1	1
Radiofrequency Interference (RFI)	1	1
Loss of or Failure to Bond	1	1
Intermittent Communication Failure	1	1
Inappropriate Audible Prompt/Feedback	1	1
Self-Activation or Keying	1	1
Disconnection	1	1
Connection Problem	1	1
Application Network Problem	1	1
Application Program Freezes, Becomes Nonfunctional	1	1
Break	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	335	335
Insufficient Information	41	41
No Patient Involvement	18	18
No Consequences Or Impact To Patient	11	11
Death	7	7
Fetal Distress	7	7
No Known Impact Or Consequence To Patient	5	5
Skin Burning Sensation	4	4
Burn, Thermal	3	3
Cardiac Arrest	3	3
Burn(s)	3	3
Superficial (First Degree) Burn	2	2
Loss Of Pulse	2	2
Asystole	2	2
Patient Problem/Medical Problem	1	1
Brain Injury	1	1
Not Applicable	1	1
No Information	1	1
Skin Inflammation/ Irritation	1	1
Head Injury	1	1
Injury	1	1
Bradycardia	1	1
Anxiety	1	1
Partial thickness (Second Degree) Burn	1	1
Unspecified Respiratory Problem	1	1
Hemorrhage/Bleeding	1	1
Therapeutic Effects, Unexpected	1	1
Hypoxia in Utero	1	1
Low Oxygen Saturation	1	1
Death, Intrauterine Fetal	1	1
Unspecified Reproductive System or Breast Problem	1	1