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TPLC
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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
64
64
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
390
390
Device Alarm System
181
181
Temperature Problem
103
103
Pressure Problem
81
81
Insufficient Flow or Under Infusion
70
70
Insufficient Information
66
66
Leak/Splash
60
60
Insufficient Heating
56
56
Overheating of Device
47
47
Appropriate Term/Code Not Available
46
46
False Alarm
35
35
Break
35
35
Device Markings/Labelling Problem
34
34
Failure to Power Up
31
31
Defective Component
30
30
Defective Alarm
29
29
Infusion or Flow Problem
28
28
Noise, Audible
27
27
Power Problem
26
26
Mechanical Problem
25
25
Crack
22
22
Failure to Calibrate
22
22
Device Sensing Problem
22
22
Component Missing
21
21
Failure to Pump
19
19
Decrease in Pressure
18
18
Inflation Problem
18
18
Excessive Heating
18
18
Calibration Problem
16
16
Connection Problem
15
15
Electrical /Electronic Property Problem
15
15
No Display/Image
13
13
No Audible Alarm
13
13
Defective Device
13
13
No Flow
13
13
Fracture
12
12
Device Emits Odor
11
11
Smoking
11
11
Display or Visual Feedback Problem
10
10
Output Problem
10
10
Improper Flow or Infusion
10
10
Pumping Problem
10
10
Air/Gas in Device
10
10
Output below Specifications
9
9
Failure to Deliver
9
9
Inaccurate Delivery
8
8
Incorrect, Inadequate or Imprecise Result or Readings
8
8
Inaccurate Flow Rate
7
7
No Pressure
7
7
Missing Value Reason
7
7
Unexpected Shutdown
7
7
Key or Button Unresponsive/not Working
6
6
Intermittent Loss of Power
6
6
Device Displays Incorrect Message
6
6
Electrical Power Problem
6
6
Failure to Sense
6
6
Display Difficult to Read
6
6
Failure to Cycle
5
5
Material Fragmentation
5
5
Loose or Intermittent Connection
5
5
Detachment of Device or Device Component
5
5
Device Damaged Prior to Use
5
5
Increased Sensitivity
5
5
Failure to Shut Off
5
5
Gas/Air Leak
5
5
Audible Prompt/Feedback Problem
5
5
Component Misassembled
4
4
Adverse Event Without Identified Device or Use Problem
4
4
Device Difficult to Maintain
4
4
Material Separation
4
4
Material Rupture
4
4
Circuit Failure
4
4
Thermal Decomposition of Device
3
3
Hole In Material
3
3
Disconnection
3
3
Restricted Flow rate
3
3
Improper or Incorrect Procedure or Method
3
3
Fitting Problem
3
3
Moisture Damage
3
3
Pumping Stopped
3
3
Failure of Device to Self-Test
3
3
Mechanical Jam
3
3
Failure to Infuse
3
3
Sparking
3
3
Contamination /Decontamination Problem
2
2
Component or Accessory Incompatibility
2
2
Device-Device Incompatibility
2
2
Difficult to Open or Close
2
2
Incomplete or Missing Packaging
2
2
Device Contamination with Body Fluid
2
2
Naturally Worn
2
2
Material Integrity Problem
2
2
Flare or Flash
2
2
Environmental Particulates
2
2
No Apparent Adverse Event
2
2
Protective Measures Problem
2
2
Unknown (for use when the device problem is not known)
2
2
Under-Sensing
2
2
Imprecision
2
2
High impedance
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
932
932
Insufficient Information
268
268
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
No Code Available
2
2
Blood Loss
2
2
Air Embolism
2
2
Burn(s)
2
2
Cardiac Arrest
2
2
Complaint, Ill-Defined
1
1
Surgical procedure, delayed
1
1
Superficial (First Degree) Burn
1
1
Non specific EKG/ECG Changes
1
1
Hemorrhage/Bleeding
1
1
Hypovolemic Shock
1
1
Unspecified Infection
1
1
Paralysis
1
1
Pneumothorax
1
1
Septic Shock
1
1
Swelling
1
1
Unspecified Heart Problem
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Estill Medical Technologies, Inc
II
Oct-21-2014
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