TPLC - Total Product Life Cycle

show TPLC since

Device	monitor, cardiac (incl. cardiotachometer & rate alarm)
Regulation Description	Cardiac monitor (including cardiotachometer and rate alarm).
Product Code	DRT
Regulation Number	870.2300
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Output Problem	77	77
Communication or Transmission Problem	38	38
Incorrect, Inadequate or Imprecise Result or Readings	34	34
Overheating of Device	32	32
Temperature Problem	31	31
Protective Measures Problem	16	16
Power Problem	16	16
Display or Visual Feedback Problem	15	15
Battery Problem	11	11
No Audible Alarm	10	10
Patient Data Problem	9	9
Complete Loss of Power	9	9
Signal Artifact/Noise	8	8
Data Problem	8	8
Unable to Obtain Readings	7	7
No Display/Image	6	6
Intermittent Communication Failure	6	6
Application Program Problem	6	6
No Device Output	5	5
Intermittent Loss of Power	4	4
Electrical /Electronic Property Problem	4	4
Wireless Communication Problem	4	4
Image Display Error/Artifact	4	4
Device Alarm System	4	4
Erratic or Intermittent Display	3	3
Pacing Problem	3	3
Appropriate Term/Code Not Available	3	3
Loss of Data	3	3
Unexpected Shutdown	3	3
Failure to Select Signal	2	2
Device Sensing Problem	2	2
Contamination /Decontamination Problem	2	2
High Readings	2	2
Premature Discharge of Battery	2	2
Unintended Electrical Shock	2	2
Break	2	2
Delayed Alarm	1	1
False Alarm	1	1
No Audible Prompt/Feedback	1	1
Unintended Application Program Shut Down	1	1
Labelling, Instructions for Use or Training Problem	1	1
Low Readings	1	1
Computer Software Problem	1	1
Application Network Problem	1	1
Alarm Not Visible	1	1
Failure to Deliver Shock/Stimulation	1	1
Device Displays Incorrect Message	1	1
Malposition of Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	226	226
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Insufficient Information	2	2
Tachycardia	2	2
Unspecified Tissue Injury	2	2
Unspecified Heart Problem	2	2
Arrhythmia	1	1
Sepsis	1	1
Cardiac Arrest	1	1
Fever	1	1
Asystole	1	1
Partial thickness (Second Degree) Burn	1	1
Respiratory Distress Syndrome of Newborns	1	1
Loss of consciousness	1	1
Low Blood Pressure/ Hypotension	1	1
Low Oxygen Saturation	1	1