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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
1. K090508
THE BELMONT BUDDY LITE FLUID WARMER
2. K112639
THE BELMONT BUDDY LITE FLUID WARMER
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
Component Missing
22
22
Failure to Calibrate
22
22
Device Sensing Problem
22
22
Failure to Pump
21
21
Decrease in Pressure
18
18
Inflation Problem
18
18
Excessive Heating
18
18
Electrical /Electronic Property Problem
16
16
Calibration Problem
16
16
Connection Problem
15
15
No Flow
14
14
Fracture
14
14
No Display/Image
13
13
No Audible Alarm
13
13
Defective Device
13
13
Device Emits Odor
12
12
Smoking
11
11
Pumping Problem
11
11
Improper Flow or Infusion
11
11
Output Problem
10
10
Display or Visual Feedback 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
Intermittent Loss of Power
6
6
Key or Button Unresponsive/not Working
6
6
Device Displays Incorrect Message
6
6
Detachment of Device or Device Component
6
6
Electrical Power Problem
6
6
Loose or Intermittent Connection
6
6
Failure to Sense
6
6
Complete Blockage
6
6
Display Difficult to Read
6
6
Failure to Cycle
5
5
Material Fragmentation
5
5
Device Damaged Prior to Use
5
5
Increased Sensitivity
5
5
Gas/Air Leak
5
5
Failure to Shut Off
5
5
Audible Prompt/Feedback Problem
5
5
Component Misassembled
4
4
Device Difficult to Maintain
4
4
Adverse Event Without Identified Device or Use Problem
4
4
Disconnection
4
4
Circuit Failure
4
4
Material Separation
4
4
Fitting Problem
4
4
Material Rupture
4
4
Improper or Incorrect Procedure or Method
4
4
Moisture Damage
3
3
Pumping Stopped
3
3
Thermal Decomposition of Device
3
3
Restricted Flow rate
3
3
Hole In Material
3
3
Mechanical Jam
3
3
Failure of Device to Self-Test
3
3
Incomplete or Missing Packaging
3
3
Failure to Infuse
3
3
Sparking
3
3
Complete Loss of Power
3
3
No Apparent Adverse Event
2
2
Incomplete or Inadequate Connection
2
2
Priming Problem
2
2
Misassembled During Installation
2
2
Misassembly During Maintenance/Repair
2
2
Contamination /Decontamination Problem
2
2
Component or Accessory Incompatibility
2
2
Electrical Shorting
2
2
Environmental Particulates
2
2
Device-Device Incompatibility
2
2
Difficult to Open or Close
2
2
Device Contamination with Body Fluid
2
2
Obstruction of Flow
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
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