TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
PHILIPS MEDICAL SYSTEMS
	SUBSTANTIALLY EQUIVALENT	2
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
	SUBSTANTIALLY EQUIVALENT	1
PHILLIPS MEDICAL SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
No Audible Prompt/Feedback	25	25
Detachment of Device or Device Component	17	17
No Audible Alarm	15	15
Device Fell	6	6
Incorrect Measurement	4	4
High Readings	4	4
Incorrect, Inadequate or Imprecise Result or Readings	4	4
Device Operates Differently Than Expected	3	3
Sparking	2	2
Fire	2	2
No Display/Image	2	2
Display or Visual Feedback Problem	1	1
Break	1	1
Continuous Firing	1	1
Moisture Damage	1	1
Nonstandard Device	1	1
Failure to Transmit Record	1	1
Device Alarm System	1	1
Inappropriate Audible Prompt/Feedback	1	1
Low Readings	1	1
Device Displays Incorrect Message	1	1
Application Program Problem	1	1
Intermittent Loss of Power	1	1
Application Program Freezes, Becomes Nonfunctional	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Output Problem	1	1
Insufficient Information	1	1
Appropriate Term/Code Not Available	1	1
Data Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	81	81
No Consequences Or Impact To Patient	3	3
Numbness	1	1
No Patient Involvement	1	1
No Known Impact Or Consequence To Patient	1	1
No Information	1	1
Insufficient Information	1	1