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TPLC
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show TPLC since
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Device
compressor, air, portable
Product Code
BTI
Regulation Number
868.6250
Device Class
2
Premarket Reviews
Manufacturer
Decision
EKOM S.R.O.
SUBSTANTIALLY EQUIVALENT
1
ORICARE, INC.
SUBSTANTIALLY EQUIVALENT
1
TRUDELL MEDICAL INTL.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
982
982
2015
294
294
2016
139
139
2017
102
102
2018
71
71
2019
114
114
2020
111
111
2021
278
278
2022
248
248
2023
325
325
2024
60
60
Device Problems
MDRs with this Device Problem
Events in those MDRs
Failure to Power Up
582
582
Device Inoperable
255
255
Output Problem
250
250
Improper Flow or Infusion
233
233
Device Operates Differently Than Expected
204
204
Decrease in Pressure
177
177
Pressure Problem
108
108
Noise, Audible
83
83
Electrical /Electronic Property Problem
73
73
Break
69
69
Product Quality Problem
68
68
Loss of Power
67
67
No Device Output
61
61
Device Displays Incorrect Message
54
54
No Pressure
51
51
Failure to Deliver
49
49
Mechanical Problem
48
48
No Flow
39
39
Device Stops Intermittently
32
32
Contamination /Decontamination Problem
22
22
Electronic Property Issue
20
20
Power Problem
20
20
Output below Specifications
19
19
Leak/Splash
18
18
Smoking
18
18
Infusion or Flow Problem
17
17
Appropriate Term/Code Not Available
13
13
Insufficient Information
12
12
Fire
12
12
Increase in Pressure
11
11
Unexpected Shutdown
11
11
Material Split, Cut or Torn
11
11
Moisture or Humidity Problem
11
11
Overheating of Device
9
9
Sticking
8
8
Device Alarm System
8
8
Contamination
8
8
Crack
8
8
Defective Device
8
8
Gas/Air Leak
8
8
Improper Device Output
8
8
Thermal Decomposition of Device
7
7
Inaccurate Delivery
7
7
Sparking
7
7
Hole In Material
6
6
Temperature Problem
6
6
Intermittent Loss of Power
5
5
Peeled/Delaminated
5
5
Unstable
5
5
Insufficient Flow or Under Infusion
5
5
Detachment Of Device Component
5
5
Circuit Failure
4
4
Degraded
4
4
Failure to Shut Off
4
4
Inaccurate Dispensing
3
3
Adverse Event Without Identified Device or Use Problem
3
3
Melted
3
3
Device Emits Odor
3
3
Failure To Run On AC/DC
3
3
Accessory Incompatible
3
3
Vibration
3
3
Power Conditioning Problem
2
2
Self-Activation or Keying
2
2
No Audible Alarm
2
2
Energy Output Problem
2
2
Loose or Intermittent Connection
2
2
Device Maintenance Issue
2
2
Material Frayed
2
2
Fluid/Blood Leak
2
2
Electrical Shorting
2
2
Failure of Device to Self-Test
2
2
Computer Operating System Problem
2
2
Arcing
2
2
Physical Resistance/Sticking
2
2
Complete Loss of Power
1
1
Unintended Electrical Shock
1
1
Application Program Problem: Medication Error
1
1
Device Handling Problem
1
1
Intermittent Energy Output
1
1
Suction Failure
1
1
Difficult to Open or Close
1
1
Electrical Power Problem
1
1
Connection Problem
1
1
Delivery System Failure
1
1
Detachment of Device or Device Component
1
1
Flare or Flash
1
1
Device Contamination with Chemical or Other Material
1
1
Material Integrity Problem
1
1
Medical Gas Supply Problem
1
1
No Apparent Adverse Event
1
1
Protective Measures Problem
1
1
Physical Property Issue
1
1
Fracture
1
1
Material Fragmentation
1
1
Unintended Power Up
1
1
Disconnection
1
1
Unintended Ejection
1
1
Gas Output Problem
1
1
Signal Artifact/Noise
1
1
Bent
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
847
847
No Consequences Or Impact To Patient
831
831
No Known Impact Or Consequence To Patient
554
554
No Patient Involvement
311
311
No Information
124
124
Missed Dose
12
12
Low Oxygen Saturation
8
8
Insufficient Information
7
7
Asthma
7
7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
Underdose
3
3
Respiratory Distress
3
3
Death
3
3
Dyspnea
3
3
Cough
2
2
Wheezing
1
1
Unspecified Respiratory Problem
1
1
No Code Available
1
1
Electric Shock
1
1
Electrocution
1
1
Fall
1
1
Hypoventilation
1
1
Hypoxia
1
1
Unspecified Infection
1
1
Irritation
1
1
Pneumonia
1
1
Urinary Retention
1
1
Burn(s)
1
1
Chronic Obstructive Pulmonary Disease (COPD)
1
1
Discomfort
1
1
Injury
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Datex-Ohmeda, Inc.
I
Jan-30-2024
2
Maquet Cardiovascular Us Sales, Llc
II
Jan-28-2014
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