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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
56
56
Device Problems
MDRs with this Device Problem
Events in those MDRs
Inadequate Filtration Process
132
132
Suction Problem
102
102
Failure to Power Up
95
95
Suction Failure
74
74
Smoking
73
73
Thermal Decomposition of Device
72
72
Material Frayed
54
54
Device Emits Odor
47
47
Incorrect Measurement
44
44
Melted
42
42
Filtration Problem
41
41
Overheating of Device
27
27
Fluid/Blood Leak
24
24
Electrical /Electronic Property Problem
22
22
No Apparent Adverse Event
19
19
Connection Problem
18
18
Incorrect, Inadequate or Imprecise Result or Readings
17
17
Circuit Failure
15
15
Decrease in Suction
14
14
Noise, Audible
13
13
Sparking
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
Vibration
7
7
Insufficient Information
7
7
Material Split, Cut or Torn
6
6
Electrical Shorting
6
6
Display or Visual Feedback Problem
5
5
Material Integrity Problem
5
5
No Display/Image
5
5
Appropriate Term/Code Not Available
4
4
Excessive Heating
4
4
Unexpected Shutdown
4
4
Failure to Clean Adequately
4
4
Decrease in Pressure
4
4
Electrical Power Problem
4
4
Degraded
4
4
Device Displays Incorrect Message
4
4
Obstruction of Flow
4
4
Device Alarm System
3
3
Image Display Error/Artifact
3
3
Pressure Problem
3
3
Arcing
3
3
Defective Device
3
3
Leak/Splash
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
654
654
No Patient Involvement
108
108
No Consequences Or Impact To Patient
82
82
Insufficient Information
31
31
No Known Impact Or Consequence To Patient
14
14
Low Oxygen Saturation
8
8
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
Airway Obstruction
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Laerdal Medical (Suzhou) Co., Ltd.
II
Jan-15-2021
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