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TPLC
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show TPLC since
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Device
warmer, blood, non-electromagnetic radiation
Product Code
BSB
Regulation Number
864.9205
Device Class
2
Premarket Reviews
Manufacturer
Decision
BELMONT INSTRUMENT CORP.
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2014
10
10
2015
11
11
2016
66
66
2017
29
29
2018
36
36
2019
147
147
2020
216
216
2021
341
341
2022
447
447
2023
292
292
2024
205
205
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
Electrical /Electronic Property Problem
16
16
Connection Problem
16
16
No Flow
15
15
Defective Device
14
14
No Audible Alarm
14
14
Device Emits Odor
13
13
No Display/Image
13
13
Improper Flow or Infusion
11
11
Smoking
11
11
Pumping Problem
11
11
Display or Visual Feedback Problem
11
11
No Pressure
10
10
Output Problem
10
10
Air/Gas in Device
10
10
Output below Specifications
9
9
Failure to Deliver
9
9
Failure to Sense
8
8
Incorrect, Inadequate or Imprecise Result or Readings
8
8
Inaccurate Delivery
8
8
Inaccurate Flow Rate
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
Swelling
1
1
Septic Shock
1
1
Unspecified Heart Problem
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Estill Medical Technologies, Inc
II
Oct-21-2014
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