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TPLC
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show TPLC since
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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
2
BLUEPOINT MEDICAL GMBH & CO. KG
SUBSTANTIALLY EQUIVALENT
1
COVIDIEN
SUBSTANTIALLY EQUIVALENT
1
COVIDIEN LLC
SUBSTANTIALLY EQUIVALENT
2
DONGGUAN LINGXIN TECHNOLOGIES CO., LTD
SUBSTANTIALLY EQUIVALENT
1
EDAN INSTRUMENTS, INC.
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
JKH USA, LLC
SUBSTANTIALLY EQUIVALENT
1
LEADTEK RESEARCH INC.
SUBSTANTIALLY EQUIVALENT
2
MASIMO CORPORATION
SUBSTANTIALLY EQUIVALENT
5
NONIN MEDICAL INC.
SUBSTANTIALLY EQUIVALENT
1
NONIN MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
2
ORANTECH INC.
SUBSTANTIALLY EQUIVALENT
1
OXITONE MEDICAL LTD.
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
2
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 FITFAITH TECHNOLOGY CO.,LTD
SUBSTANTIALLY EQUIVALENT
1
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
1
SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
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
1
SHENZHEN YIMI LIFE-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
WESPER INC.
SUBSTANTIALLY EQUIVALENT
1
XHALE, INC
SUBSTANTIALLY EQUIVALENT
1
XIAMEN ACURIO INSTRUMENTS CO., LTD
SUBSTANTIALLY EQUIVALENT
1
XINKANG MEDICAL INSTRUMENT CO. LTD.
SUBSTANTIALLY EQUIVALENT
1
XUZHOU YONGKANG ELECTRONIC SCIENCE TECHNOLOGY CO., LTD
SUBSTANTIALLY EQUIVALENT
1
ZHUHAI LINTE MEDICAL INSTRUMENT CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2017
1191
1191
2018
693
693
2019
549
549
2020
426
426
2021
555
555
2022
203
203
Device Problems
MDRs with this Device Problem
Events in those MDRs
Incorrect Measurement
687
687
Display or Visual Feedback Problem
418
418
Low Readings
302
302
Sensing Intermittently
272
272
Inappropriate or Unexpected Reset
204
204
Device Stops Intermittently
194
194
Device Alarm System
168
168
Device Operates Differently Than Expected
165
165
Break
132
132
Failure To Run On AC/DC
128
128
High Readings
123
123
No Audible Alarm
102
102
Crack
86
86
No Display/Image
74
74
Corroded
72
72
Unable to Obtain Readings
64
64
Contamination /Decontamination Problem
64
64
Patient Device Interaction Problem
55
55
Image Display Error/Artifact
42
42
Poor Quality Image
36
36
Appropriate Term/Code Not Available
36
36
Incorrect, Inadequate or Imprecise Resultor Readings
35
35
Battery Problem
34
34
Communication or Transmission Problem
33
33
Device Displays Incorrect Message
27
27
Contamination
27
27
Erratic or Intermittent Display
26
26
Circuit Failure
26
26
Loose or Intermittent Connection
25
25
Adverse Event Without Identified Device or Use Problem
25
25
Noise, Audible
24
24
Temperature Problem
23
23
Patient-Device Incompatibility
23
23
Device Sensing Problem
23
23
Failure to Power Up
23
23
Defective Device
20
20
Defective Alarm
19
19
Power Problem
18
18
Insufficient Information
18
18
Material Integrity Problem
16
16
No Apparent Adverse Event
15
15
Biological Environmental Factor
14
14
Failure to Sense
14
14
Failure to Read Input Signal
13
13
Sparking
13
13
Charging Problem
13
13
Output Problem
11
11
Failure to Analyze Signal
11
11
Display Difficult to Read
11
11
Computer Software Problem
11
11
Use of Device Problem
10
10
Device Emits Odor
10
10
Defective Component
10
10
Missing Information
10
10
Device Damaged Prior to Use
9
9
Overheating of Device
9
9
Device Markings/Labelling Problem
8
8
Therapeutic or Diagnostic Output Failure
7
7
Premature Discharge of Battery
7
7
Disconnection
6
6
Electrical /Electronic Property Problem
6
6
Peeled/Delaminated
6
6
Mechanical Problem
6
6
Smoking
6
6
Inappropriate/Inadequate Shock/Stimulation
6
6
No Device Output
6
6
Human-Device Interface Problem
6
6
Deformation Due to Compressive Stress
6
6
Material Split, Cut or Torn
5
5
Physical Resistance/Sticking
5
5
Nonstandard Device
5
5
False Reading From Device Non-Compliance
5
5
Thermal Decomposition of Device
4
4
Failure to Charge
4
4
Failure To Adhere Or Bond
4
4
Component Missing
4
4
Inaccurate Information
4
4
Application Program Freezes, Becomes Nonfunctional
4
4
Low Test Results
3
3
Ambient Noise Problem
3
3
Connection Problem
3
3
Device Fell
3
3
Unexpected Shutdown
3
3
Protective Measures Problem
3
3
Data Problem
3
3
Mechanics Altered
3
3
Manufacturing, Packaging or Shipping Problem
3
3
False Alarm
3
3
Loss of or Failure to Bond
3
3
Material Separation
3
3
Inaudible or Unclear Audible Prompt/Feedback
3
3
Device Difficult to Program or Calibrate
2
2
Melted
2
2
Leak/Splash
2
2
Failure to Run on Battery
2
2
Low Audible Alarm
2
2
Unintended Ejection
2
2
Fire
2
2
False Device Output
2
2
Material Deformation
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
1931
1931
No Clinical Signs, Symptoms or Conditions
608
608
No Known Impact Or Consequence To Patient
400
400
No Patient Involvement
295
295
Death
55
55
Burn(s)
53
53
Insufficient Information
53
53
Pressure Sores
50
50
Injury
35
35
No Information
35
35
Low Oxygen Saturation
22
22
Skin Irritation
16
16
Tissue Damage
13
13
Burn, Thermal
11
11
Respiratory Distress
8
8
Rash
7
7
Superficial (First Degree) Burn
7
7
Unspecified Tissue Injury
6
6
Electric Shock
6
6
Cardiac Arrest
6
6
Erythema
6
6
Cyanosis
5
5
Hypoxia
5
5
Laceration(s)
5
5
Tissue Breakdown
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
Skin Tears
4
4
Partial thickness (Second Degree) Burn
3
3
No Code Available
3
3
Seizures
3
3
Burning Sensation
3
3
Bradycardia
3
3
Bruise/Contusion
2
2
Cardiopulmonary Arrest
2
2
Congestive Heart Failure
2
2
Anoxia
2
2
Swelling
2
2
Pain
2
2
Convulsion/Seizure
2
2
Full thickness (Third Degree) Burn
2
2
Not Applicable
2
2
High Oxygen Saturation
2
2
Respiratory Failure
2
2
Skin Erosion
2
2
Ulcer
2
2
Brain Injury
1
1
Deformity/ Disfigurement
1
1
Reaction
1
1
Coma
1
1
Irritability
1
1
Bronchopneumonia
1
1
Increased Respiratory Rate
1
1
Diminished Pulse Pressure
1
1
Discomfort
1
1
Complaint, Ill-Defined
1
1
Foreign Body In Patient
1
1
Blister
1
1
Skin Disorders
1
1
Skin Inflammation/ Irritation
1
1
Missing Value Reason
1
1
Unintended Extubation
1
1
Paralysis
1
1
Pneumonia
1
1
Necrosis
1
1
Ischemia
1
1
Tachycardia
1
1
Septic Shock
1
1
Shock
1
1
Scarring
1
1
Aspiration/Inhalation
1
1
Asthma
1
1
Failure to Anastomose
1
1
Abrasion
1
1
Dyspnea
1
1
Hematoma
1
1
High Blood Pressure/ Hypertension
1
1
Hyperventilation
1
1
Low Blood Pressure/ Hypotension
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Covidien LLC
II
Feb-02-2017
2
Merge Healthcare, Inc.
II
Jun-29-2017
3
Nonin Medical, Inc
II
Mar-28-2017
4
Oridion Medical 1987 Ltd.
II
Oct-03-2018
5
Xhale Assurance, Inc.
II
Jul-30-2019
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