Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
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
104
104
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
400
400
Device Alarm System
186
186
Temperature Problem
104
104
Pressure Problem
91
91
Insufficient Flow or Under Infusion
71
71
Insufficient Information
66
66
Leak/Splash
62
62
Insufficient Heating
57
57
Overheating of Device
48
48
Appropriate Term/Code Not Available
46
46
Break
36
36
False Alarm
35
35
Device Markings/Labelling Problem
34
34
Defective Alarm
32
32
Failure to Power Up
31
31
Defective Component
31
31
Infusion or Flow Problem
28
28
Noise, Audible
28
28
Power Problem
27
27
Mechanical Problem
26
26
Crack
23
23
Device Sensing Problem
22
22
Failure to Calibrate
22
22
Component Missing
22
22
Failure to Pump
21
21
Inflation Problem
18
18
Decrease in Pressure
18
18
Excessive Heating
18
18
Calibration Problem
16
16
Electrical /Electronic Property Problem
16
16
Connection Problem
15
15
No Flow
14
14
Fracture
14
14
No Audible Alarm
13
13
No Display/Image
13
13
Defective Device
13
13
Device Emits Odor
12
12
Pumping Problem
11
11
Improper Flow or Infusion
11
11
Smoking
11
11
Output Problem
10
10
Display or Visual Feedback Problem
10
10
Air/Gas in Device
10
10
Failure to Deliver
9
9
Output below Specifications
9
9
Incorrect, Inadequate or Imprecise Result or Readings
8
8
Inaccurate Delivery
8
8
Missing Value Reason
7
7
No Pressure
7
7
Unexpected Shutdown
7
7
Inaccurate Flow Rate
7
7
Display Difficult to Read
6
6
Failure to Sense
6
6
Device Displays Incorrect Message
6
6
Electrical Power Problem
6
6
Key or Button Unresponsive/not Working
6
6
Complete Blockage
6
6
Intermittent Loss of Power
6
6
Detachment of Device or Device Component
6
6
Loose or Intermittent Connection
6
6
Device Damaged Prior to Use
5
5
Audible Prompt/Feedback Problem
5
5
Failure to Shut Off
5
5
Material Fragmentation
5
5
Failure to Cycle
5
5
Gas/Air Leak
5
5
Increased Sensitivity
5
5
Improper or Incorrect Procedure or Method
4
4
Component Misassembled
4
4
Circuit Failure
4
4
Adverse Event Without Identified Device or Use Problem
4
4
Device Difficult to Maintain
4
4
Material Separation
4
4
Fitting Problem
4
4
Material Rupture
4
4
Disconnection
4
4
Thermal Decomposition of Device
3
3
Complete Loss of Power
3
3
Moisture Damage
3
3
Restricted Flow rate
3
3
Pumping Stopped
3
3
Failure to Infuse
3
3
Failure of Device to Self-Test
3
3
Hole In Material
3
3
Incomplete or Missing Packaging
3
3
Mechanical Jam
3
3
Sparking
3
3
Misassembled During Installation
2
2
Burst Container or Vessel
2
2
Flare or Flash
2
2
Corroded
2
2
Material Integrity Problem
2
2
Device Contamination with Body Fluid
2
2
Priming Problem
2
2
Contamination /Decontamination Problem
2
2
High impedance
2
2
Unintended Power Up
2
2
Unknown (for use when the device problem is not known)
2
2
No Apparent Adverse Event
2
2
Use of Device Problem
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
966
966
Insufficient Information
275
275
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
-
-