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
Material Fragmentation	16	16
Device Handling Problem	16	16
Insufficient Information	16	16
Entrapment of Device	9	9
Detachment of Device or Device Component	9	9
Failure to Read Input Signal	9	9
Difficult to Remove	9	9
Detachment Of Device Component	6	6
Component Missing	6	6
Human Factors Issue	5	5
Positioning Problem	5	5
Failure to Disconnect	4	4
Separation Failure	4	4
Device Operates Differently Than Expected	3	3
Use of Device Problem	3	3
Incorrect, Inadequate or Imprecise Result or Readings	3	3
Difficult or Delayed Separation	2	2
Physical Resistance/Sticking	2	2
Connection Problem	2	2
Device Dislodged or Dislocated	2	2
Microbial Contamination of Device	2	2
Defective Component	2	2
Therapeutic or Diagnostic Output Failure	2	2
Defective Device	2	2
Patient-Device Incompatibility	2	2
Signal Artifact/Noise	2	2
Device Contamination with Chemical or Other Material	2	2
Unable to Obtain Readings	2	2
Patient Device Interaction Problem	1	1
Scratched Material	1	1
Disconnection	1	1
Fitting Problem	1	1
Human-Device Interface Problem	1	1
Device Reprocessing Problem	1	1
Loose or Intermittent Connection	1	1
Sticking	1	1
Improper or Incorrect Procedure or Method	1	1
No Device Output	1	1
Malposition of Device	1	1
Incorrect Measurement	1	1
Structural Problem	1	1
Shelf Life Exceeded	1	1
Difficult to Insert	1	1
Bent	1	1
Data Problem	1	1
Overheating of Device	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
No Clinical Signs, Symptoms or Conditions	17	17
Foreign Body In Patient	17	17
Abrasion	12	12
Tissue Damage	11	11
Unspecified Infection	7	7
Laceration(s)	6	6
Needle Stick/Puncture	6	6
Insufficient Information	5	5
Head Injury	4	4
Injury	4	4
Pregnancy	4	4
No Code Available	4	4
Localized Skin Lesion	3	3
Skin Tears	3	3
No Consequences Or Impact To Patient	3	3
Swelling	2	2
Abscess	2	2
Unspecified Tissue Injury	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Hematoma	1	1
Purulent Discharge	1	1
Inflammation	1	1
Blood Loss	1	1
Burn, Thermal	1	1
Skin Inflammation/ Irritation	1	1
Staphylococcus Aureus	1	1
No Information	1	1
Post Traumatic Wound Infection	1	1
Nausea	1	1
No Patient Involvement	1	1
Vomiting	1	1
Pain	1	1
Abdominal Pain	1	1
Hair Loss	1	1
Cerebrospinal Fluid Leakage	1	1
Meningitis	1	1
Hemorrhage/Bleeding	1	1
Vessel Or Plaque, Device Embedded In	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