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TPLC
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Device
analyzer, gas, carbon-dioxide, gaseous-phase
Product Code
CCK
Regulation Number
868.1400
Device Class
2
Premarket Reviews
Manufacturer
Decision
BEIJING KINGST COMMERCIAL & TRADE CO.,LTD.
SUBSTANTIALLY EQUIVALENT
2
BLUEPOINT MEDICAL GMBH & CO. KG
SUBSTANTIALLY EQUIVALENT
1
CMI HEALTH INC.
SUBSTANTIALLY EQUIVALENT
1
COVIDIEN
SUBSTANTIALLY EQUIVALENT
1
COVIDIEN LLC
SUBSTANTIALLY EQUIVALENT
2
DRAEGERWERK AG & CO. KGAA
SUBSTANTIALLY EQUIVALENT
1
ENDURE INDUSTRIES INC
SUBSTANTIALLY EQUIVALENT
1
ENGINEERED MEDICAL SYSTEMS INC.
SUBSTANTIALLY EQUIVALENT
1
GE HEALTHCARE FINLAND OY
SUBSTANTIALLY EQUIVALENT
2
MASIMO CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MAXTEC, LLC
SUBSTANTIALLY EQUIVALENT
1
MEDIPINES CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MEDITERA TIBBI MALZEME SAN. VE TIC. A.S.
SUBSTANTIALLY EQUIVALENT
1
ORANTECH INC.
SUBSTANTIALLY EQUIVALENT
1
ORIDION MEDICAL 1987 LTD.
SUBSTANTIALLY EQUIVALENT
3
PNEUMA THERAPEUTICS, INC.
SUBSTANTIALLY EQUIVALENT
1
POM MEDICAL, LLC
SUBSTANTIALLY EQUIVALENT
1
1. K172365
Panoramic Oxygen Mask (POM)
RESPIRION, INC.
SUBSTANTIALLY EQUIVALENT
1
REVOLUTIONARY MEDICAL DEVICES, INC.
SUBSTANTIALLY EQUIVALENT
1
SOUTHMEDIC INC.
SUBSTANTIALLY EQUIVALENT
1
TYLENOL MEDICAL INSTRUMENTS CO., LTD
SUBSTANTIALLY EQUIVALENT
1
UNIMED MEDICAL SUPPLIES, INC.
SUBSTANTIALLY EQUIVALENT
1
VYAIRE MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
63
63
2019
141
141
2020
2302
2302
2021
2272
2272
2022
2475
2475
2023
1638
1638
2024
689
689
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
3285
3285
Communication or Transmission Problem
2408
2408
Crack
2274
2274
Appropriate Term/Code Not Available
944
944
Corroded
927
927
Failure to Calibrate
851
851
Incorrect, Inadequate or Imprecise Result or Readings
731
731
Computer Software Problem
564
564
Device Alarm System
560
560
Contamination
509
509
Failure of Device to Self-Test
474
474
No Device Output
463
463
No Apparent Adverse Event
409
409
Loose or Intermittent Connection
400
400
Calibration Problem
352
352
Circuit Failure
299
299
Insufficient Information
295
295
Output Problem
218
218
Device Sensing Problem
180
180
Physical Resistance/Sticking
116
116
Failure to Read Input Signal
108
108
Display Difficult to Read
77
77
Display or Visual Feedback Problem
74
74
Application Program Freezes, Becomes Nonfunctional
61
61
Unable to Obtain Readings
55
55
Misassembled
48
48
Incorrect Measurement
42
42
Pumping Stopped
37
37
Failure to Power Up
37
37
Peeled/Delaminated
37
37
Low Readings
33
33
High Readings
32
32
Naturally Worn
28
28
Degraded
27
27
Application Program Problem
26
26
Failure to Cycle
25
25
Electrical /Electronic Property Problem
24
24
Power Problem
22
22
Gas Output Problem
20
20
Mechanical Problem
18
18
Temperature Problem
17
17
Missing Information
17
17
Image Display Error/Artifact
17
17
No Display/Image
16
16
Device Markings/Labelling Problem
15
15
Erratic or Intermittent Display
14
14
Unexpected Shutdown
13
13
Noise, Audible
13
13
False Alarm
12
12
Use of Device Problem
11
11
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
6361
6361
No Patient Involvement
2990
2990
No Consequences Or Impact To Patient
132
132
No Known Impact Or Consequence To Patient
114
114
Insufficient Information
111
111
No Information
81
81
Unintended Extubation
13
13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
7
7
Unspecified Tissue Injury
4
4
Cardiac Arrest
3
3
Foreign Body In Patient
3
3
Death
2
2
Respiratory Distress
2
2
Hypoxia
2
2
Low Oxygen Saturation
2
2
Cyanosis
1
1
Superficial (First Degree) Burn
1
1
Patient Problem/Medical Problem
1
1
Hypersensitivity/Allergic reaction
1
1
Respiratory Arrest
1
1
Perforation
1
1
Injury
1
1
Chest Pain
1
1
Discomfort
1
1
Cardiopulmonary Arrest
1
1
Laceration(s)
1
1
Pain
1
1
Anxiety
1
1
Cough
1
1
Pressure Sores
1
1
Inadequate Pain Relief
1
1
Extubate
1
1
Respiratory Insufficiency
1
1
Lethargy
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
CareFusion 303, Inc.
II
Aug-30-2019
2
Covidien Llc
II
Dec-01-2020
3
GE Healthcare, LLC
I
Jan-10-2020
4
Oridion Medical 1987 Ltd.
II
Oct-03-2018
5
Smiths Medical ASD Inc.
II
Jul-06-2018
6
Southmedic, Inc.
II
Jul-24-2021
7
Southmedic, Inc.
II
Jan-25-2018
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