TPLC - Total Product Life Cycle

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Device	system, monitoring, perinatal
Regulation Description	Perinatal monitoring system and accessories.
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
EDAN INSTRUMENTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
HUNTLEIGH HEALTHCARE , LTD.
	SUBSTANTIALLY EQUIVALENT	2
PERIGEN, INC.
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
	SUBSTANTIALLY EQUIVALENT	1
SIBEL HEALTH, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
No Audible Alarm	133	133
No Audible Prompt/Feedback	112	112
Incorrect Measurement	88	88
Incorrect, Inadequate or Imprecise Result or Readings	37	37
High Readings	35	36
Defective Alarm	31	31
High Test Results	29	29
Insufficient Information	20	20
Unable to Obtain Readings	17	17
Erratic Results	13	13
Device Alarm System	11	11
Adverse Event Without Identified Device or Use Problem	9	9
Appropriate Term/Code Not Available	6	6
Audible Prompt/Feedback Problem	6	6
No Visual Prompts/Feedback	6	6
Overheating of Device	5	5
Signal Artifact/Noise	5	5
Use of Device Problem	4	4
No Device Output	3	3
Failure to Transmit Record	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Protective Measures Problem	3	3
Erratic or Intermittent Display	3	3
Circuit Failure	3	3
Inaudible or Unclear Audible Prompt/Feedback	3	3
Output Problem	3	3
Improper or Incorrect Procedure or Method	2	2
False Positive Result	2	2
Application Program Freezes, Becomes Nonfunctional	2	2
Low Readings	2	2
False Alarm	2	2
Patient Device Interaction Problem	2	2
Image Display Error/Artifact	2	2
Failure to Sense	2	2
Inaccurate Flow Rate	1	1
Failure to Power Up	1	1
Imprecision	1	1
Volume Accuracy Problem	1	1
Fire	1	1
Device Handling Problem	1	1
Disconnection	1	1
Inappropriate/Inadequate Shock/Stimulation	1	1
Detachment of Device or Device Component	1	1
No Apparent Adverse Event	1	1
Low Audible Alarm	1	1
Computer Software Problem	1	1
Poor Quality Image	1	1
Unintended Electrical Shock	1	1
Failure to Clean Adequately	1	1
Application Network Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	474	475
Insufficient Information	49	49
Fetal Distress	10	10
Burn(s)	4	4
Hypoxia in Utero	4	4
Skin Burning Sensation	4	4
Hypoxia	3	3
Superficial (First Degree) Burn	2	2
Cardiac Arrest	2	2
Respiratory Acidosis	2	2
Asystole	2	2
Hemorrhage/Bleeding	2	2
Encephalopathy	1	1
Uterine Perforation	1	1
Sleep Dysfunction	1	1
No Information	1	1
Skin Inflammation/ Irritation	1	1
Head Injury	1	1
Burn, Thermal	1	1
Blister	1	1
Thrombosis/Thrombus	1	1
Bradycardia	1	1
Tachycardia	1	1
Unspecified Respiratory Problem	1	1
No Consequences Or Impact To Patient	1	1
Low Oxygen Saturation	1	1
Bruise/Contusion	1	1
Unspecified Reproductive System or Breast Problem	1	1