TPLC - Total Product Life Cycle

show TPLC since

Device	warmer, blood, non-electromagnetic radiation
Product Code	BSB
Regulation Number	864.9205
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	421	421
Device Alarm System	204	204
Temperature Problem	121	121
Pressure Problem	97	97
Insufficient Flow or Under Infusion	71	71
Leak/Splash	70	70
Insufficient Information	66	66
Insufficient Heating	63	63
Overheating of Device	51	51
Appropriate Term/Code Not Available	46	46
Break	40	40
Defective Component	36	36
False Alarm	35	35
Device Markings/Labelling Problem	35	35
Failure to Power Up	34	34
Defective Alarm	34	34
Noise, Audible	31	31
Infusion or Flow Problem	28	28
Power Problem	27	27
Failure to Pump	27	27
Mechanical Problem	26	26
Crack	25	25
Component Missing	24	24
Device Sensing Problem	23	23
Decrease in Pressure	22	22
Failure to Calibrate	22	22
Excessive Heating	20	20
Inflation Problem	19	19
Fracture	17	17
Calibration Problem	16	16
Connection Problem	16	16
Electrical /Electronic Property Problem	16	16
No Flow	15	15
Defective Device	14	14
No Audible Alarm	14	14
No Display/Image	13	13
Device Emits Odor	13	13
Pumping Problem	11	11
Display or Visual Feedback Problem	11	11
Smoking	11	11
Improper Flow or Infusion	11	11
Output Problem	10	10
No Pressure	10	10
Air/Gas in Device	10	10
Output below Specifications	9	9
Failure to Deliver	9	9
Inaccurate Delivery	8	8
Failure to Sense	8	8
Incorrect, Inadequate or Imprecise Result or Readings	8	8
Missing Value Reason	7	7

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1050	1050
Insufficient Information	296	296
Not Applicable	152	152
No Information	131	131
No Patient Involvement	107	107
No Consequences Or Impact To Patient	84	84
No Known Impact Or Consequence To Patient	74	74
Death	10	10
Missing Value Reason	5	5
Air Embolism	2	2
No Code Available	2	2
Blood Loss	2	2
Cardiac Arrest	2	2
Burn(s)	2	2
Hemorrhage/Bleeding	2	2
Non specific EKG/ECG Changes	1	1
Hypovolemic Shock	1	1
Unspecified Infection	1	1
Superficial (First Degree) Burn	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Pneumothorax	1	1
Complaint, Ill-Defined	1	1
Surgical procedure, delayed	1	1
Paralysis	1	1
Septic Shock	1	1
Swelling	1	1
Unspecified Heart Problem	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Estill Medical Technologies, Inc	II	Oct-21-2014