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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
5
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
BODIMETRICS, LLC
SUBSTANTIALLY EQUIVALENT
1
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
8
NONIN MEDICAL INC.
SUBSTANTIALLY EQUIVALENT
1
NONIN MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
2
ORANTECH INC.
SUBSTANTIALLY EQUIVALENT
1
OWLET BABY CARE, 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 BRAV ELECTRONIC TECHNOLOGIES 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 CHANGKUN TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
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
2
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
4
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
553
553
2022
479
479
2023
271
271
Device Problems
MDRs with this Device Problem
Events in those MDRs
Incorrect Measurement
433
433
Sensing Intermittently
317
317
Low Readings
313
313
Display or Visual Feedback Problem
234
234
Device Alarm System
177
177
Inappropriate or Unexpected Reset
171
171
High Readings
131
131
Break
130
130
Patient Device Interaction Problem
88
88
Crack
87
87
Unexpected Shutdown
81
81
Corroded
72
72
No Audible Alarm
69
69
Incorrect, Inadequate or Imprecise Result or Readings
68
68
Contamination /Decontamination Problem
64
64
Image Display Error/Artifact
62
62
Unable to Obtain Readings
51
51
Temperature Problem
47
47
Communication or Transmission Problem
41
41
Poor Quality Image
37
37
Appropriate Term/Code Not Available
36
36
Adverse Event Without Identified Device or Use Problem
32
32
Noise, Audible
31
31
Patient-Device Incompatibility
30
30
Failure to Power Up
28
28
Circuit Failure
28
28
Contamination
27
27
No Display/Image
27
27
Battery Problem
27
27
Defective Device
25
25
Device Displays Incorrect Message
24
24
Failure to Analyze Signal
21
21
Loose or Intermittent Connection
20
20
Insufficient Information
20
20
Material Integrity Problem
19
19
Defective Alarm
19
19
Mechanical Problem
18
18
Failure To Run On AC/DC
17
17
No Apparent Adverse Event
17
17
Erratic or Intermittent Display
16
16
Failure to Read Input Signal
16
16
Device Stops Intermittently
15
15
Failure to Sense
15
15
Computer Software Problem
15
15
Charging Problem
15
15
Biological Environmental Factor
14
14
Device Damaged Prior to Use
14
14
Defective Component
14
14
Use of Device Problem
14
14
Output Problem
13
13
Device Operates Differently Than Expected
12
12
Sparking
11
11
Power Problem
11
11
Overheating of Device
11
11
Display Difficult to Read
11
11
Delayed Program or Algorithm Execution
11
11
Missing Information
10
10
Device Emits Odor
10
10
Device Markings/Labelling Problem
9
9
Therapeutic or Diagnostic Output Failure
8
8
Device Sensing Problem
8
8
Material Separation
8
8
Premature Discharge of Battery
8
8
Material Split, Cut or Torn
7
7
Inaccurate Information
7
7
Application Program Freezes, Becomes Nonfunctional
6
6
No Visual Prompts/Feedback
6
6
Deformation Due to Compressive Stress
6
6
Ambient Noise Problem
6
6
Disconnection
6
6
Smoking
6
6
No Device Output
6
6
Peeled/Delaminated
6
6
Failure to Run on Battery
6
6
Physical Resistance/Sticking
5
5
Human-Device Interface Problem
5
5
Material Deformation
5
5
Manufacturing, Packaging or Shipping Problem
4
4
Component Missing
4
4
Electrical /Electronic Property Problem
4
4
Loss of or Failure to Bond
4
4
Failure to Charge
3
3
False Alarm
3
3
False Reading From Device Non-Compliance
3
3
Fire
3
3
Inaudible or Unclear Audible Prompt/Feedback
3
3
Low Test Results
3
3
Connection Problem
3
3
Failure of Device to Self-Test
3
3
Protective Measures Problem
3
3
Mechanics Altered
3
3
Device Fell
3
3
Data Problem
3
3
Separation Problem
3
3
Erratic Results
2
2
Key or Button Unresponsive/not Working
2
2
Naturally Worn
2
2
Failure to Shut Off
2
2
High Test Results
2
2
Malposition of Device
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
1040
1040
No Patient Involvement
228
228
Insufficient Information
89
89
Pressure Sores
85
85
No Known Impact Or Consequence To Patient
77
77
Burn(s)
59
59
Death
38
38
Injury
32
32
No Information
23
23
Low Oxygen Saturation
22
22
Skin Irritation
14
14
Unspecified Tissue Injury
14
14
Superficial (First Degree) Burn
13
13
Tissue Damage
12
12
Burn, Thermal
10
10
Blister
10
10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
9
9
Erythema
8
8
Rash
7
7
Laceration(s)
5
5
Hypoxia
4
4
Inflammation
4
4
Cyanosis
4
4
Cardiac Arrest
4
4
Partial thickness (Second Degree) Burn
4
4
Skin Erosion
4
4
Tissue Breakdown
3
3
Bradycardia
3
3
Skin Discoloration
3
3
Ulcer
3
3
Pain
3
3
Respiratory Distress
2
2
Burning Sensation
2
2
Swelling
2
2
Bruise/Contusion
2
2
Dyspnea
2
2
Electric Shock
2
2
High Oxygen Saturation
2
2
Respiratory Failure
2
2
Full thickness (Third Degree) Burn
2
2
Not Applicable
2
2
Convulsion/Seizure
2
2
No Code Available
2
2
Skin Inflammation/ Irritation
2
2
Nodule
1
1
Missing Value Reason
1
1
Increased Sensitivity
1
1
Skin Burning Sensation
1
1
Skin Disorders
1
1
Heart Failure/Congestive Heart Failure
1
1
Respiratory Arrest
1
1
Joint Contracture
1
1
Increased Respiratory Rate
1
1
Deformity/ Disfigurement
1
1
Ventilator Dependent
1
1
Reaction
1
1
Coma
1
1
Irritability
1
1
Bronchopneumonia
1
1
Diminished Pulse Pressure
1
1
Discomfort
1
1
Hematoma
1
1
Hyperventilation
1
1
Low Blood Pressure/ Hypotension
1
1
Cardiopulmonary Arrest
1
1
Chest Pain
1
1
Anemia
1
1
Anoxia
1
1
Apnea
1
1
Asthma
1
1
Tachycardia
1
1
Septic Shock
1
1
Paralysis
1
1
Pneumonia
1
1
Undesired Nerve Stimulation
1
1
Unintended Extubation
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Masimo Corporation
II
Jun-21-2023
2
Oridion Medical 1987 Ltd.
II
Oct-03-2018
3
Xhale Assurance, Inc.
II
Jul-30-2019
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