TPLC - Total Product Life Cycle

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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	91	91
Incorrect, Inadequate or Imprecise Result or Readings	43	43
Communication or Transmission Problem	42	42
Overheating of Device	33	33
Temperature Problem	32	32
Display or Visual Feedback Problem	21	21
Power Problem	20	20
Protective Measures Problem	16	16
Complete Loss of Power	12	12
Battery Problem	12	12
Unable to Obtain Readings	11	11
No Audible Alarm	10	10
Intermittent Communication Failure	9	9
No Display/Image	9	9
Signal Artifact/Noise	9	9
Patient Data Problem	8	8
Data Problem	8	8
Application Program Problem	7	7
Image Display Error/Artifact	6	6
No Device Output	5	5
Device Alarm System	4	4
Electrical /Electronic Property Problem	4	4
Intermittent Loss of Power	4	4
Wireless Communication Problem	3	3
Appropriate Device Problem Term/Code Not Available	3	3
Erratic or Intermittent Display	3	3
Loss of Data	3	3
Unintended Electrical Shock	2	2
High Readings	2	2
Contamination /Decontamination Problem	2	2
Unintended Application Program Shut Down	2	2
Failure to Select Signal	2	2
Device Sensing Problem	2	2
Pacing Problem	2	2
Premature Discharge of Battery	2	2
Unexpected Shutdown	2	2
Smoking	1	1
Alarm Not Visible	1	1
Delayed Alarm	1	1
Battery Problem: Low Impedance	1	1
False Alarm	1	1
No Audible Prompt/Feedback	1	1
Labelling, Instructions for Use or Training Problem	1	1
Low Readings	1	1
Computer Software Problem	1	1
Malposition of Device	1	1
Application Network Problem	1	1
Break	1	1
Device Displays Incorrect Message	1	1
Failure to Read Input Signal	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	259	259
Insufficient Information	3	3
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	3	3
Arrhythmia	2	2
Tachycardia	2	2
Unspecified Tissue Injury	2	2
Unspecified Heart Problem	2	2
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