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TPLC
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Device
oximeter
Product Code
DQA
Regulation Number
870.2700
Device Class
2
Premarket Reviews
Manufacturer
Decision
APK TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
3
BEIJING SAFE HEART TECHNOLOGY LTD.
SUBSTANTIALLY EQUIVALENT
1
BELUN TECHNOLOGY COMPANY LIMITED
SUBSTANTIALLY EQUIVALENT
3
BIO-BEAT TECHNOLOGIES LTD.
SUBSTANTIALLY EQUIVALENT
1
BIOBEAT TECHNOLOGIES LTD.
SUBSTANTIALLY EQUIVALENT
3
CHRONISENSE MEDICAL, LTD.
SUBSTANTIALLY EQUIVALENT
1
COVIDIEN LLC
SUBSTANTIALLY EQUIVALENT
2
DONGGUAN LINGXIN TECHNOLOGIES CO., LTD
SUBSTANTIALLY EQUIVALENT
1
EDAN INSTRUMENTS, INC.
SUBSTANTIALLY EQUIVALENT
1
EMPATICA S.R.L.
SUBSTANTIALLY EQUIVALENT
1
GUANGDONG LONG YAO ELECTRONIC TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
HANCOCK MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
HITACHI HEALTHCARE AMERICAS
SUBSTANTIALLY EQUIVALENT
1
HUIZHOU XIAOOU TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
HUNAN ACCURATE BIO-MEDICAL TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
JKH USA, LLC
SUBSTANTIALLY EQUIVALENT
1
LEADTEK RESEARCH INC.
SUBSTANTIALLY EQUIVALENT
2
MASIMO CORPORATION
SUBSTANTIALLY EQUIVALENT
6
NONIN MEDICAL INC.
SUBSTANTIALLY EQUIVALENT
1
NONIN MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
2
ORANTECH INC.
SUBSTANTIALLY EQUIVALENT
1
S.L.P. LTD.
SUBSTANTIALLY EQUIVALENT
1
SHANGHAI BERRY ELECTRONIC TECH CO., LTD
SUBSTANTIALLY EQUIVALENT
1
SHENZHEN AEON TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
2
SHENZHEN AOJ MEDICAL TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
SHENZHEN BSX TECHNOLOGY ELECTRONICS CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
SHENZHEN CAREMED MEDICAL TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
SHENZHEN CHANGKE CONNECT ELECTRONICS CO., LTD.
SUBSTANTIALLY EQUIVALENT
2
SHENZHEN CORERAY TECHNOLOGY, LTD.
SUBSTANTIALLY EQUIVALENT
1
SHENZHEN CREATIVE INDUSTRY CO., LTD.
SUBSTANTIALLY EQUIVALENT
3
SHENZHEN GREATMADE TECH LIMITED
SUBSTANTIALLY EQUIVALENT
1
SHENZHEN HEXIN ZONDAN MEDICAL EQUIPMENT CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
SHENZHEN IMDK MEDICAL TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
2
SHENZHEN LEPU INTELLIGENT MEDICAL EQUIPMENT CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD
SUBSTANTIALLY EQUIVALENT
1
SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
SHENZHEN MERICONN TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
SHENZHEN NARIG BIO-MEDICAL TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
SHENZHEN RAYSINTONE TECHNOLOGY CO., LTD
SUBSTANTIALLY EQUIVALENT
1
SHENZHEN SINO-K MEDICAL TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
SHENZHEN UPNMED EQUIPMENT CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
SHENZHEN VIATOM TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
2
SHENZHEN WITLEAF MEDICAL ELECTRONICS CO.,LTD
SUBSTANTIALLY EQUIVALENT
1
SHENZHEN YIMI LIFE-TECHNOLOGY CO.,LTD.
SUBSTANTIALLY EQUIVALENT
1
SHENZHEN ZHENGKANG TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
SPRY HEALTH, INC.
SUBSTANTIALLY EQUIVALENT
1
STRYKER SUSTAINABILITY SOLUTIONS
SUBSTANTIALLY EQUIVALENT
1
SUREPULSE MEDICAL LIMITED
SUBSTANTIALLY EQUIVALENT
1
SURGICAL INSTRUMENT SERVICE AND SAVINGS INC (DBA MEDLINE
SUBSTANTIALLY EQUIVALENT
1
TAIWAN AULISA MEDICAL DEVICES TECHNOLOGIES, INC.
SUBSTANTIALLY EQUIVALENT
3
TAIWAN BIOPHOTONIC CORPORATION
SUBSTANTIALLY EQUIVALENT
1
TRUE WEARABLES, INC.
SUBSTANTIALLY EQUIVALENT
1
UNIMED MEDICAL SUPPLIES, INC.
SUBSTANTIALLY EQUIVALENT
1
WESPER INC.
SUBSTANTIALLY EQUIVALENT
1
XIAMEN ACURIO INSTRUMENTS CO., LTD
SUBSTANTIALLY EQUIVALENT
1
XINKANG MEDICAL INSTRUMENT CO. LTD.
SUBSTANTIALLY EQUIVALENT
1
ZHUHAI LINTE MEDICAL INSTRUMENT CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
693
693
2019
549
549
2020
426
426
2021
555
555
2022
479
479
Device Problems
MDRs with this Device Problem
Events in those MDRs
Incorrect Measurement
419
419
Sensing Intermittently
299
299
Low Readings
283
283
Display or Visual Feedback Problem
232
232
Device Alarm System
163
163
Inappropriate or Unexpected Reset
161
161
Break
128
128
High Readings
125
125
Crack
86
86
Corroded
72
72
Patient Device Interaction Problem
67
67
No Audible Alarm
67
67
Contamination /Decontamination Problem
64
64
Incorrect, Inadequate or Imprecise Result or Readings
62
62
Image Display Error/Artifact
46
46
Unable to Obtain Readings
42
42
Communication or Transmission Problem
39
39
Poor Quality Image
35
35
Appropriate Term/Code Not Available
35
35
Temperature Problem
34
34
Noise, Audible
28
28
Contamination
27
27
Battery Problem
26
26
Failure to Power Up
26
26
Circuit Failure
26
26
No Display/Image
24
24
Defective Device
21
21
Device Displays Incorrect Message
21
21
Loose or Intermittent Connection
20
20
Material Integrity Problem
19
19
Mechanical Problem
18
18
Insufficient Information
18
18
Failure To Run On AC/DC
17
17
Defective Alarm
17
17
Adverse Event Without Identified Device or Use Problem
17
17
Unexpected Shutdown
17
17
Patient-Device Incompatibility
16
16
Failure to Read Input Signal
16
16
Device Stops Intermittently
15
15
Charging Problem
15
15
Failure to Sense
15
15
Computer Software Problem
15
15
Failure to Analyze Signal
15
15
Erratic or Intermittent Display
14
14
No Apparent Adverse Event
14
14
Biological Environmental Factor
14
14
Defective Component
13
13
Output Problem
13
13
Device Operates Differently Than Expected
12
12
Sparking
11
11
Display Difficult to Read
11
11
Overheating of Device
11
11
Use of Device Problem
10
10
Device Damaged Prior to Use
10
10
Power Problem
10
10
Missing Information
10
10
Device Emits Odor
10
10
Device Markings/Labelling Problem
9
9
Premature Discharge of Battery
8
8
Therapeutic or Diagnostic Output Failure
7
7
Material Separation
7
7
Delayed Program or Algorithm Execution
7
7
Inaccurate Information
6
6
No Visual Prompts/Feedback
6
6
Device Sensing Problem
6
6
Peeled/Delaminated
6
6
Deformation Due to Compressive Stress
6
6
No Device Output
6
6
Ambient Noise Problem
6
6
Disconnection
6
6
Material Split, Cut or Torn
5
5
Physical Resistance/Sticking
5
5
Human-Device Interface Problem
5
5
Component Missing
4
4
Smoking
4
4
Application Program Freezes, Becomes Nonfunctional
4
4
Electrical /Electronic Property Problem
4
4
Failure to Run on Battery
4
4
Manufacturing, Packaging or Shipping Problem
3
3
Mechanics Altered
3
3
Connection Problem
3
3
Loss of or Failure to Bond
3
3
Failure to Charge
3
3
Separation Problem
3
3
False Reading From Device Non-Compliance
3
3
Protective Measures Problem
3
3
Device Fell
3
3
Data Problem
3
3
Low Test Results
3
3
Inaudible or Unclear Audible Prompt/Feedback
3
3
False Alarm
3
3
Inappropriate/Inadequate Shock/Stimulation
2
2
Failure to Advance
2
2
Failure of Device to Self-Test
2
2
Material Deformation
2
2
Fire
2
2
Erratic Results
2
2
Melted
2
2
Labelling, Instructions for Use or Training Problem
2
2
Failure to Align
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
1200
1200
No Clinical Signs, Symptoms or Conditions
844
844
No Patient Involvement
229
229
No Known Impact Or Consequence To Patient
77
77
Insufficient Information
68
68
Pressure Sores
59
59
Burn(s)
51
51
Death
38
38
Injury
32
32
No Information
23
23
Low Oxygen Saturation
19
19
Skin Irritation
14
14
Tissue Damage
12
12
Unspecified Tissue Injury
10
10
Burn, Thermal
10
10
Blister
7
7
Superficial (First Degree) Burn
7
7
Rash
7
7
Erythema
5
5
Laceration(s)
5
5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
5
5
Cyanosis
4
4
Skin Erosion
4
4
Hypoxia
4
4
Cardiac Arrest
4
4
Pain
3
3
Tissue Breakdown
3
3
Partial thickness (Second Degree) Burn
3
3
Bradycardia
3
3
Bruise/Contusion
2
2
No Code Available
2
2
Electric Shock
2
2
Not Applicable
2
2
Swelling
2
2
Inflammation
2
2
Respiratory Failure
2
2
Convulsion/Seizure
2
2
Ulcer
2
2
Full thickness (Third Degree) Burn
2
2
High Oxygen Saturation
2
2
Respiratory Distress
2
2
Burning Sensation
2
2
Discomfort
1
1
Tachycardia
1
1
Reaction
1
1
Paralysis
1
1
Pneumonia
1
1
Undesired Nerve Stimulation
1
1
Chest Pain
1
1
Hyperventilation
1
1
Anoxia
1
1
Asthma
1
1
Nodule
1
1
Deformity/ Disfigurement
1
1
Coma
1
1
Anemia
1
1
Cardiopulmonary Arrest
1
1
Heart Failure/Congestive Heart Failure
1
1
Unintended Extubation
1
1
Increased Sensitivity
1
1
Septic Shock
1
1
Dyspnea
1
1
Hematoma
1
1
Low Blood Pressure/ Hypotension
1
1
Apnea
1
1
Diminished Pulse Pressure
1
1
Missing Value Reason
1
1
Skin Disorders
1
1
Skin Inflammation/ Irritation
1
1
Irritability
1
1
Bronchopneumonia
1
1
Increased Respiratory Rate
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Oridion Medical 1987 Ltd.
II
Oct-03-2018
2
Xhale Assurance, Inc.
II
Jul-30-2019
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