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TPLC
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Device
transmitters and receivers, physiological signal, radiofrequency
Product Code
DRG
Regulation Number
870.2910
Device Class
2
Premarket Reviews
Manufacturer
Decision
ALIO, INC.
SUBSTANTIALLY EQUIVALENT
1
BIOINTELLISENSE INC.
SUBSTANTIALLY EQUIVALENT
1
BIOLNTELLISENSE INC.
SUBSTANTIALLY EQUIVALENT
1
BOSTON SCIENTIFIC CORPORATION
SUBSTANTIALLY EQUIVALENT
1
BRAVEHEART WIRELESS, INC.
SUBSTANTIALLY EQUIVALENT
1
CARDIOLINE S.P.A
SUBSTANTIALLY EQUIVALENT
1
CARETAKER MEDICAL, LLC
SUBSTANTIALLY EQUIVALENT
1
COMARCH HEALTHCARE SA
SUBSTANTIALLY EQUIVALENT
1
ELASTIC CARE INCORPORATED
SUBSTANTIALLY EQUIVALENT
1
ERGOLINE GMBH
SUBSTANTIALLY EQUIVALENT
1
GRAFTWORX, INC. DBA ALIO
SUBSTANTIALLY EQUIVALENT
1
HMICRO, INC.
SUBSTANTIALLY EQUIVALENT
1
ISANSYS LIFECARE LTD
SUBSTANTIALLY EQUIVALENT
1
LIFESIGNALS, INC.
SUBSTANTIALLY EQUIVALENT
2
LR MED INC
SUBSTANTIALLY EQUIVALENT
1
MC10 INC.
SUBSTANTIALLY EQUIVALENT
1
MORTARA INSTRUMENT INC
SUBSTANTIALLY EQUIVALENT
1
PHILIPS MEDICAL SYSTEMS
SUBSTANTIALLY EQUIVALENT
1
ROOTI LABS LTD.
SUBSTANTIALLY EQUIVALENT
1
SIBEL HEALTH INC.
SUBSTANTIALLY EQUIVALENT
2
SIBEL INC.
SUBSTANTIALLY EQUIVALENT
2
SIGKNOW BIOMEDICAL CO.,LTD.
SUBSTANTIALLY EQUIVALENT
1
SYNERGEN TECHNOLOGY LABS LLC
SUBSTANTIALLY EQUIVALENT
1
UNITED HEALTH GROUP INC.
SUBSTANTIALLY EQUIVALENT
1
VISICU INC.
SUBSTANTIALLY EQUIVALENT
1
VITAL CONNECT, INC.
SUBSTANTIALLY EQUIVALENT
1
VITALCONNECT, INC.
SUBSTANTIALLY EQUIVALENT
5
VITLS INC.
SUBSTANTIALLY EQUIVALENT
1
VIVALNK, INC.
SUBSTANTIALLY EQUIVALENT
1
VIVIFY HEALTH, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2017
484
484
2018
166
166
2019
70
70
2020
82
82
2021
107
107
2022
44
44
2023
19
19
2024
19
19
Device Problems
MDRs with this Device Problem
Events in those MDRs
Communication or Transmission Problem
253
253
Thermal Decomposition of Device
245
245
Failure to Power Up
167
167
Adverse Event Without Identified Device or Use Problem
89
89
Power Conditioning Problem
46
46
Output Problem
35
35
Device Operates Differently Than Expected
29
29
Charred
28
28
Intermittent Communication Failure
22
22
Loss of Power
18
18
Computer Software Problem
18
18
Overheating of Device
16
16
Signal Artifact/Noise
14
14
Radio Signal Problem
14
14
Application Program Problem
11
11
No Display/Image
10
10
Power Problem
10
10
Wireless Communication Problem
9
9
Smoking
9
9
Incorrect, Inadequate or Imprecise Result or Readings
9
9
Temperature Problem
8
8
Sparking
7
7
Break
7
7
Device Operational Issue
7
7
Appropriate Term/Code Not Available
7
7
Protective Measures Problem
7
7
Device Alarm System
6
6
Device Inoperable
6
6
Device Issue
6
6
Melted
6
6
Device Emits Odor
5
5
Incomplete or Inadequate Connection
5
5
Computer System Security Problem
5
5
Device Sensing Problem
4
4
Device Displays Incorrect Message
4
4
Unintended Application Program Shut Down
4
4
Failure to Read Input Signal
4
4
Computer Operating System Problem
3
3
Data Problem
3
3
Electrical /Electronic Property Problem
3
3
Radiofrequency Interference (RFI)
3
3
Failure to Advance
2
2
Connection Problem
2
2
Incorrect Interpretation of Signal
2
2
Application Interface Becomes Non-Functional Or Program Exits Abnormally
2
2
No Audible Alarm
2
2
Invalid Sensing
2
2
Display or Visual Feedback Problem
2
2
Defective Component
2
2
Telemetry Discrepancy
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
640
640
No Clinical Signs, Symptoms or Conditions
253
253
No Consequences Or Impact To Patient
81
81
No Information
33
33
No Patient Involvement
13
13
Death
5
5
Insufficient Information
5
5
Electric Shock
2
2
Burn(s)
2
2
Shock
2
2
Ulceration
2
2
Contact Dermatitis
2
2
Partial thickness (Second Degree) Burn
2
2
Foreign Body In Patient
1
1
Unspecified Tissue Injury
1
1
Tissue Damage
1
1
Hypoxia
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Biointellisense Inc.
II
Aug-14-2024
2
Boston Scientific Corporation
II
Sep-13-2017
3
Nihon Kohden America Inc
II
Mar-02-2021
4
Philips Visicu
II
Apr-04-2017
5
Vitalconnect Inc.
II
Jul-10-2020
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