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TPLC
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Device
apparatus, suction, ward use, portable, ac-powered
Product Code
JCX
Regulation Number
878.4780
Device Class
2
Premarket Reviews
Manufacturer
Decision
ACARE TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
DORNOCH MEDICAL SYSTEMS
SUBSTANTIALLY EQUIVALENT
1
GUANGZHOU EASYCESS MEDICAL CO., LTD
SUBSTANTIALLY EQUIVALENT
1
STRYKER INSTRUMENTS
SUBSTANTIALLY EQUIVALENT
1
TAIWAN BIOMATERIAL CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
132
132
2020
89
89
2021
227
227
2022
215
215
2023
187
187
2024
102
102
Device Problems
MDRs with this Device Problem
Events in those MDRs
Inadequate Filtration Process
132
132
Suction Problem
103
103
Failure to Power Up
96
96
Smoking
80
80
Suction Failure
74
74
Thermal Decomposition of Device
72
72
Material Frayed
54
54
Device Emits Odor
48
48
Incorrect Measurement
44
44
Melted
43
43
Filtration Problem
41
41
Contamination /Decontamination Problem
29
29
Overheating of Device
28
28
Fluid/Blood Leak
24
24
Electrical /Electronic Property Problem
22
22
Connection Problem
19
19
No Apparent Adverse Event
19
19
Incorrect, Inadequate or Imprecise Result or Readings
17
17
Circuit Failure
15
15
Sparking
15
15
Decrease in Suction
15
15
Noise, Audible
13
13
Intermittent Loss of Power
8
8
Fire
8
8
Power Problem
8
8
Output Problem
8
8
Material Deformation
8
8
Device Handling Problem
7
7
Misconnection
7
7
Insufficient Information
7
7
Vibration
7
7
Material Split, Cut or Torn
6
6
Electrical Shorting
6
6
Display or Visual Feedback Problem
5
5
Appropriate Term/Code Not Available
5
5
Material Integrity Problem
5
5
No Display/Image
5
5
Failure to Clean Adequately
4
4
Excessive Heating
4
4
Degraded
4
4
Unexpected Shutdown
4
4
Obstruction of Flow
4
4
Device Displays Incorrect Message
4
4
Electrical Power Problem
4
4
Decrease in Pressure
4
4
Leak/Splash
3
3
Defective Device
3
3
Arcing
3
3
Device Alarm System
3
3
Pressure Problem
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
693
693
No Patient Involvement
108
108
No Consequences Or Impact To Patient
82
82
Insufficient Information
33
33
No Known Impact Or Consequence To Patient
14
14
Low Oxygen Saturation
8
8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
No Code Available
3
3
Laceration(s)
3
3
Aneurysm
2
2
Unspecified Infection
1
1
Pneumothorax
1
1
Aspiration/Inhalation
1
1
Paralysis
1
1
Exposure to Body Fluids
1
1
Fall
1
1
Shock
1
1
Tissue Damage
1
1
Partial thickness (Second Degree) Burn
1
1
Airway Obstruction
1
1
Ventilator Dependent
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Laerdal Medical (Suzhou) Co., Ltd.
II
Jan-15-2021
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