TPLC - Total Product Life Cycle

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Device	electrode, circular (spiral), scalp and applicator
Product Code	HGP
Regulation Number	884.2675
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	37	37
Adverse Event Without Identified Device or Use Problem	21	21
Insufficient Information	16	16
Device Handling Problem	16	16
Material Fragmentation	16	16
Entrapment of Device	9	9
Difficult to Remove	9	9
Failure to Read Input Signal	9	9
Detachment of Device or Device Component	9	9
Component Missing	6	6
Detachment Of Device Component	6	6
Positioning Problem	5	5
Human Factors Issue	5	5
Failure to Disconnect	4	4
Separation Failure	4	4
Use of Device Problem	3	3
Device Operates Differently Than Expected	3	3
Incorrect, Inadequate or Imprecise Result or Readings	3	3
Unable to Obtain Readings	2	2
Signal Artifact/Noise	2	2
Device Dislodged or Dislocated	2	2
Device Contamination with Chemical or Other Material	2	2
Patient-Device Incompatibility	2	2
Connection Problem	2	2
Defective Component	2	2
Microbial Contamination of Device	2	2
Defective Device	2	2
Physical Resistance/Sticking	2	2
Difficult or Delayed Separation	2	2
Therapeutic or Diagnostic Output Failure	2	2
Human-Device Interface Problem	1	1
Scratched Material	1	1
Patient Device Interaction Problem	1	1
Data Problem	1	1
Malposition of Device	1	1
Improper or Incorrect Procedure or Method	1	1
Fitting Problem	1	1
Structural Problem	1	1
Bent	1	1
Device Reprocessing Problem	1	1
Difficult to Insert	1	1
Loose or Intermittent Connection	1	1
No Device Output	1	1
Overheating of Device	1	1
Disconnection	1	1
Shelf Life Exceeded	1	1
Sticking	1	1
Device Inoperable	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	40	40
Post Operative Wound Infection	31	31
Device Embedded In Tissue or Plaque	23	23
Foreign Body In Patient	17	17
No Clinical Signs, Symptoms or Conditions	16	16
Abrasion	12	12
Tissue Damage	11	11
Unspecified Infection	7	7
Laceration(s)	6	6
Needle Stick/Puncture	6	6
Insufficient Information	4	4
No Code Available	4	4
Pregnancy	4	4
Injury	4	4
Head Injury	4	4
No Consequences Or Impact To Patient	3	3
Localized Skin Lesion	3	3
Skin Tears	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Unspecified Tissue Injury	2	2
Swelling	2	2
Abscess	2	2
Cerebrospinal Fluid Leakage	1	1
Purulent Discharge	1	1
Hair Loss	1	1
Hematoma	1	1
Hemorrhage/Bleeding	1	1
Inflammation	1	1
Vessel Or Plaque, Device Embedded In	1	1
Pain	1	1
Staphylococcus Aureus	1	1
Meningitis	1	1
Skin Inflammation/ Irritation	1	1
Burn, Thermal	1	1
Blood Loss	1	1
No Patient Involvement	1	1
No Information	1	1
Post Traumatic Wound Infection	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Philips North America, LLC	II	May-02-2019
2	Philips North America Llc	II	Jan-06-2023
3	Vital Signs Devices, a GE Healthcare Company	II	Nov-16-2012