TPLC - Total Product Life Cycle

• 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

MDR Year	MDR Reports	MDR Events
2019	41	41
2020	19	19
2021	71	71
2022	87	87
2023	69	69
2024	11	11

Device Problems	MDRs with this Device Problem	Events in those MDRs
No Audible Prompt/Feedback	83	83
No Audible Alarm	65	65
Material Integrity Problem	18	18
Defective Alarm	17	17
Adverse Event Without Identified Device or Use Problem	16	16
No Apparent Adverse Event	16	16
Insufficient Information	14	14
Device Alarm System	13	13
Incorrect Measurement	13	13
Incorrect, Inadequate or Imprecise Result or Readings	10	10
Electrical /Electronic Property Problem	7	7
Crack	5	5
Circuit Failure	4	4
Audible Prompt/Feedback Problem	4	4
Manufacturing, Packaging or Shipping Problem	3	3
Output Problem	3	3
Protective Measures Problem	3	3
Failure to Sense	3	3
Electrical Shorting	3	3
Unable to Obtain Readings	3	3
Failure to Transmit Record	3	3
Overheating of Device	3	3
Use of Device Problem	3	3
Improper or Incorrect Procedure or Method	2	2
False Alarm	2	2
Erratic or Intermittent Display	2	2
Image Display Error/Artifact	2	2
Device Displays Incorrect Message	2	2
Therapeutic or Diagnostic Output Failure	2	2
No Device Output	2	2
Operating System Becomes Nonfunctional	2	2
Appropriate Term/Code Not Available	2	2
Patient Device Interaction Problem	2	2
Device Fell	1	1
Unintended Electrical Shock	1	1
Device Handling Problem	1	1
Noise, Audible	1	1
Application Program Freezes, Becomes Nonfunctional	1	1
Intermittent Communication Failure	1	1
Failure to Clean Adequately	1	1
Missing Information	1	1
Erratic Results	1	1
Misassembly by Users	1	1
Patient-Device Incompatibility	1	1
Application Network Problem	1	1
Calibration Problem	1	1
Connection Problem	1	1
Detachment of Device or Device Component	1	1
Device Sensing Problem	1	1
Infusion or Flow Problem	1	1
Inappropriate/Inadequate Shock/Stimulation	1	1
Imprecision	1	1
Inaccurate Flow Rate	1	1
Disconnection	1	1
Computer Software Problem	1	1
Signal Artifact/Noise	1	1
Loss of or Failure to Bond	1	1
Break	1	1
Material Perforation	1	1
Inappropriate Audible Prompt/Feedback	1	1
Inaudible or Unclear Audible Prompt/Feedback	1	1
Radiofrequency Interference (RFI)	1	1
High Readings	1	1
Low Readings	1	1
Defective Device	1	1
Pitted	1	1
Failure to Power Up	1	1
Poor Quality Image	1	1
Energy Output Problem	1	1
Self-Activation or Keying	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	196	196
Insufficient Information	30	30
No Patient Involvement	18	18
No Consequences Or Impact To Patient	11	11
Death	7	7
No Known Impact Or Consequence To Patient	5	5
Skin Burning Sensation	4	4
Fetal Distress	4	4
Burn(s)	3	3
Cardiac Arrest	3	3
Burn, Thermal	3	3
Loss Of Pulse	2	2
Superficial (First Degree) Burn	2	2
Asystole	2	2
Unspecified Respiratory Problem	1	1
Unspecified Reproductive System or Breast Problem	1	1
Bradycardia	1	1
Partial thickness (Second Degree) Burn	1	1
Not Applicable	1	1
No Information	1	1
Patient Problem/Medical Problem	1	1
Hypoxia in Utero	1	1
Brain Injury	1	1
Anxiety	1	1
Injury	1	1
Low Oxygen Saturation	1	1
Death, Intrauterine Fetal	1	1
Head Injury	1	1
Hemorrhage/Bleeding	1	1
Therapeutic Effects, Unexpected	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Pacific Medical Group Inc.	II	Feb-04-2020