TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
D.T. DAVIS ENTERPRISES LTD. T/A HOVERTECH INT'L
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	20	20
Detachment Of Device Component	13	13
Detachment of Device or Device Component	13	13
Adverse Event Without Identified Device or Use Problem	12	12
Use of Device Problem	12	12
Device Tipped Over	10	10
Device Handling Problem	10	10
Device Operates Differently Than Expected	8	8
Inadequate or Insufficient Training	8	8
Device Slipped	7	7
Component Falling	4	4
Corroded	4	4
Insufficient Information	4	4
Appropriate Term/Code Not Available	3	3
Torn Material	3	3
Unintended Movement	3	3
Unintended System Motion	3	3
Improper or Incorrect Procedure or Method	3	3
Bent	2	2
Unstable	2	2
Material Separation	2	2
Material Frayed	2	2
Labelling, Instructions for Use or Training Problem	2	2
Crack	2	2
Electrical /Electronic Property Problem	2	2
Misassembly by Users	2	2
Sharp Edges	2	2
Naturally Worn	2	2
Device Fell	1	1
Physical Resistance/Sticking	1	1
Positioning Problem	1	1
Failure to Auto Stop	1	1
Human Factors Issue	1	1
Human-Device Interface Problem	1	1
Material Deformation	1	1
Material Erosion	1	1
Fluid/Blood Leak	1	1
Device Reprocessing Problem	1	1
Collapse	1	1
Material Discolored	1	1
Loose or Intermittent Connection	1	1
Mechanical Problem	1	1
Migration or Expulsion of Device	1	1
Misconnection	1	1
Failure to Read Input Signal	1	1
Overheating of Device	1	1
Off-Label Use	1	1
Sparking	1	1
Connection Problem	1	1
Smoking	1	1
Inaccurate Synchronization	1	1
Device Inoperable	1	1
Unknown (for use when the device problem is not known)	1	1
Solder Joint Fracture	1	1
Fumes or Vapors	1	1
Split	1	1
Separation Failure	1	1
Defective Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Fall	55	55
No Known Impact Or Consequence To Patient	17	17
Bone Fracture(s)	15	15
Laceration(s)	14	14
Bruise/Contusion	13	13
No Clinical Signs, Symptoms or Conditions	13	13
No Consequences Or Impact To Patient	11	11
Death	8	8
Pain	7	7
Head Injury	7	7
Injury	6	6
No Information	5	5
Hematoma	4	4
Swelling	3	3
Distress	3	3
No Code Available	2	2
Hip Fracture	2	2
Tissue Damage	2	2
Concussion	2	2
Rupture	1	1
Sepsis	1	1
Spinal Column Injury	1	1
Hemorrhage/Bleeding	1	1
Contusion	1	1
Headache	1	1
Quadriplegia	1	1
Skin Tears	1	1
No Patient Involvement	1	1
Insufficient Information	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Complaint, Ill-Defined	1	1