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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
3M COMPANY
SUBSTANTIALLY EQUIVALENT
2
AFRAME DIGITAL, INC.
SUBSTANTIALLY EQUIVALENT
1
ALCATEL-LUCENT CANADA INC.
SUBSTANTIALLY EQUIVALENT
1
ALIO, INC.
SUBSTANTIALLY EQUIVALENT
1
ARRAYENT HEALTH LLC D/B/A AMBIO HEALTH
SUBSTANTIALLY EQUIVALENT
1
ASCOT TECHNOLOGIES, INC.
SUBSTANTIALLY EQUIVALENT
1
BIOCOMFORT DIAGNOSTICS GMBH & CO. KG
SUBSTANTIALLY EQUIVALENT
1
BIOINTELLISENSE INC.
SUBSTANTIALLY EQUIVALENT
1
BIOLNTELLISENSE INC.
SUBSTANTIALLY EQUIVALENT
1
BL HEALTHCARE, INC.
SUBSTANTIALLY EQUIVALENT
2
BOSTON SCIENTIFIC CORPORATION
SUBSTANTIALLY EQUIVALENT
1
BRAVEHEART WIRELESS, INC.
SUBSTANTIALLY EQUIVALENT
1
CARDIOCOM LLC
SUBSTANTIALLY EQUIVALENT
1
CARDIOLINE S.P.A
SUBSTANTIALLY EQUIVALENT
2
CAREFUSION 303, INC.
SUBSTANTIALLY EQUIVALENT
1
CAREMATIX INC.
SUBSTANTIALLY EQUIVALENT
1
CARETAKER MEDICAL, LLC
SUBSTANTIALLY EQUIVALENT
1
CELLCO PARTNERSHIP D/B/A VERIZON WIRELESS
SUBSTANTIALLY EQUIVALENT
1
CELLO PARTNERSHIP D/B/A VERIZON WIRELESS
SUBSTANTIALLY EQUIVALENT
1
CERNER CORP.
SUBSTANTIALLY EQUIVALENT
1
COMARCH HEALTHCARE SA
SUBSTANTIALLY EQUIVALENT
1
CONFIDANT INC.
SUBSTANTIALLY EQUIVALENT
1
CONSTANT CARE, LLC
SUBSTANTIALLY EQUIVALENT
2
CONTINUITY HEALTH SOLUTIONS
SUBSTANTIALLY EQUIVALENT
1
DIGIO2 INTERNATIONAL CO., LTD
SUBSTANTIALLY EQUIVALENT
1
ELASTIC CARE INCORPORATED
SUBSTANTIALLY EQUIVALENT
1
ELCAM MEDICAL A.C.A.L.
SUBSTANTIALLY EQUIVALENT
1
EMERGO EUROPE CONSULTING BV
SUBSTANTIALLY EQUIVALENT
1
ENTRA HEALTH SYSTEMS
SUBSTANTIALLY EQUIVALENT
1
ERGOLINE GMBH
SUBSTANTIALLY EQUIVALENT
1
EXPRESS MD SOLUTIONS, LLC
SUBSTANTIALLY EQUIVALENT
1
GRAFTWORX, INC. DBA ALIO
SUBSTANTIALLY EQUIVALENT
1
HEALTHANYWHERE, AN IGEACARE SYSTEM COMPANY
SUBSTANTIALLY EQUIVALENT
1
HEALTHINTERLINK, LLC
SUBSTANTIALLY EQUIVALENT
1
HMICRO, INC.
SUBSTANTIALLY EQUIVALENT
1
HONEYWELL HOMMED
SUBSTANTIALLY EQUIVALENT
1
HONEYWELL HOMMED, LLC
SUBSTANTIALLY EQUIVALENT
3
HOSPIRA, INC.
SUBSTANTIALLY EQUIVALENT
1
IMETRIKUS, INC.
SUBSTANTIALLY EQUIVALENT
1
INTEL CORP.
SUBSTANTIALLY EQUIVALENT
1
INTEL CORPORATION DIGITAL HEALTH GROUP
SUBSTANTIALLY EQUIVALENT
1
INTEL-GE CARE INNOVATIONS LLC
SUBSTANTIALLY EQUIVALENT
2
INTOUCH HEALTH, INC.
SUBSTANTIALLY EQUIVALENT
2
ISANSYS LIFECARE LTD
SUBSTANTIALLY EQUIVALENT
1
LG ELECTRONICS
SUBSTANTIALLY EQUIVALENT
1
LIFELINE SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
1
LIFESIGNALS, INC.
SUBSTANTIALLY EQUIVALENT
2
LR MED INC
SUBSTANTIALLY EQUIVALENT
1
MC10 INC.
SUBSTANTIALLY EQUIVALENT
1
MEDAPPS INC., DBA ALERE CONNECT
SUBSTANTIALLY EQUIVALENT
2
MEDAPPS, INC.
SUBSTANTIALLY EQUIVALENT
2
MEDICOMP, INC.
SUBSTANTIALLY EQUIVALENT
2
MORTARA INSTRUMENT INC
SUBSTANTIALLY EQUIVALENT
1
MORTARA INSTRUMENT, INC.
SUBSTANTIALLY EQUIVALENT
1
NIHON KOHDEN CORP.
SUBSTANTIALLY EQUIVALENT
1
OPTUMHEALTH CARE SOLUTIONS, INC.
SUBSTANTIALLY EQUIVALENT
1
PHILIPS MEDICAL SYSTEMS
SUBSTANTIALLY EQUIVALENT
1
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
SUBSTANTIALLY EQUIVALENT
1
POLYMAP WIRELESS, LLC
SUBSTANTIALLY EQUIVALENT
1
ROOTI LABS LTD.
SUBSTANTIALLY EQUIVALENT
1
SAMSUNG ELECTRONICS CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
SANITAS, INC.
SUBSTANTIALLY EQUIVALENT
2
SIBEL HEALTH INC.
SUBSTANTIALLY EQUIVALENT
1
SIBEL INC.
SUBSTANTIALLY EQUIVALENT
2
SIGKNOW BIOMEDICAL CO.,LTD.
SUBSTANTIALLY EQUIVALENT
1
ST. JUDE MEDICAL SYSTEMS AB
SUBSTANTIALLY EQUIVALENT
2
SYNERGEN TECHNOLOGY LABS LLC
SUBSTANTIALLY EQUIVALENT
1
TAIDOC TECHNOLOGY CORPORATION
SUBSTANTIALLY EQUIVALENT
2
TELEMEDCARE PTY LTD
SUBSTANTIALLY EQUIVALENT
1
TUNSTALL HEALTHCARE
SUBSTANTIALLY EQUIVALENT
1
UNITED HEALTH GROUP INC.
SUBSTANTIALLY EQUIVALENT
1
VIGNET INC.
SUBSTANTIALLY EQUIVALENT
1
VISICU INC.
SUBSTANTIALLY EQUIVALENT
1
VISICU, INC.
SUBSTANTIALLY EQUIVALENT
1
VITAL CONNECT INC.
SUBSTANTIALLY EQUIVALENT
1
VITAL CONNECT, INC
SUBSTANTIALLY EQUIVALENT
1
VITAL CONNECT, INC.
SUBSTANTIALLY EQUIVALENT
2
VITALCONNECT, INC.
SUBSTANTIALLY EQUIVALENT
5
VITLS INC.
SUBSTANTIALLY EQUIVALENT
1
VIVALNK, INC.
SUBSTANTIALLY EQUIVALENT
1
VIVIFY HEALTH, INC.
SUBSTANTIALLY EQUIVALENT
1
VOCARE, INC
SUBSTANTIALLY EQUIVALENT
1
WALDO HEALTH
SUBSTANTIALLY EQUIVALENT
1
WATERMARK MEDICAL
SUBSTANTIALLY EQUIVALENT
2
ZEPHYR TECHNOLOGY CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
97
97
2015
130
130
2016
182
182
2017
484
484
2018
166
166
2019
70
70
2020
82
82
2021
107
107
2022
44
44
2023
19
19
2024
12
12
Device Problems
MDRs with this Device Problem
Events in those MDRs
Thermal Decomposition of Device
336
336
Communication or Transmission Problem
279
279
Failure to Power Up
177
177
Device Operates Differently Than Expected
126
126
Adverse Event Without Identified Device or Use Problem
100
100
Power Conditioning Problem
85
85
Charred
82
82
Device Inoperable
56
56
Overheating of Device
48
48
Output Problem
35
35
Intermittent Communication Failure
22
22
Temperature Problem
21
21
Loss of Power
19
19
Melted
18
18
Computer Software Problem
17
17
Break
16
16
Wireless Communication Problem
16
16
Power Problem
16
16
No Display/Image
15
15
Radio Signal Problem
15
15
Smoking
14
14
Signal Artifact/Noise
14
14
Device Stops Intermittently
11
11
Noise, Audible
11
11
Incorrect, Inadequate or Imprecise Result or Readings
11
11
Device Emits Odor
10
10
Application Program Problem
10
10
Sparking
10
10
Device Displays Incorrect Message
9
9
Device Operational Issue
8
8
Failure to Fire
7
7
Battery Problem
7
7
Appropriate Term/Code Not Available
7
7
Protective Measures Problem
7
7
Device Issue
7
7
Device Alarm System
7
7
Electrical /Electronic Property Problem
6
6
Data Problem
5
5
Device Sensing Problem
5
5
Failure to Read Input Signal
5
5
Radiofrequency Interference (RFI)
5
5
Fire
5
5
Computer Operating System Problem
5
5
Incomplete or Inadequate Connection
5
5
Burst Container or Vessel
4
4
Inappropriate/Inadequate Shock/Stimulation
4
4
Application Interface Becomes Non-Functional Or Program Exits Abnormally
3
3
Defective Component
3
3
Computer System Security Problem
3
3
Unintended Application Program Shut Down
3
3
Connection Problem
3
3
Electrical Shorting
3
3
Display or Visual Feedback Problem
3
3
Crack
2
2
Split
2
2
Low Battery
2
2
Moisture Damage
2
2
Device Markings/Labelling Problem
2
2
Improper Alarm
2
2
Image Display Error/Artifact
2
2
Detachment Of Device Component
2
2
Material Separation
2
2
Telemetry Discrepancy
2
2
Incorrect Interpretation of Signal
2
2
Patient Data Problem
2
2
Invalid Sensing
2
2
Premature Discharge of Battery
2
2
Failure to Transmit Record
2
2
Inappropriate or Unexpected Reset
2
2
No Audible Alarm
2
2
Incorrect Measurement
2
2
Programming Issue
2
2
Operating System Becomes Nonfunctional
2
2
Unintended Electrical Shock
2
2
False Alarm
2
2
Failure to Advance
2
2
Loss of Data
2
2
Charging Problem
1
1
Material Integrity Problem
1
1
Issue With Displayed Error Message
1
1
Application Program Problem: Parameter Calculation Error
1
1
Product Quality Problem
1
1
Failure To Service
1
1
Corroded
1
1
Failure to Capture
1
1
Material Discolored
1
1
Improper or Incorrect Procedure or Method
1
1
Electronic Property Issue
1
1
Application Program Version or Upgrade Problem
1
1
Failure to Cycle
1
1
Water softener regeneration cycle, mistiming of
1
1
Measurement System Incompatibility
1
1
Application Security Problem
1
1
No Apparent Adverse Event
1
1
Therapeutic or Diagnostic Output Failure
1
1
Component Missing
1
1
Failure to Interrogate
1
1
Circuit Failure
1
1
High Readings
1
1
Application Program Freezes, Becomes Nonfunctional
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
961
961
No Clinical Signs, Symptoms or Conditions
248
248
No Consequences Or Impact To Patient
136
136
No Information
41
41
No Patient Involvement
29
29
Death
6
6
Burn(s)
6
6
Shock
4
4
Insufficient Information
4
4
Electric Shock
3
3
Ulceration
2
2
Weight Changes
2
2
Contact Dermatitis
2
2
Partial thickness (Second Degree) Burn
2
2
Shock from Patient Lead(s)
2
2
Missing Value Reason
1
1
Unspecified Tissue Injury
1
1
Weakness
1
1
Complaint, Ill-Defined
1
1
Burn, Thermal
1
1
Diminished Pulse Pressure
1
1
Foreign Body In Patient
1
1
Tissue Damage
1
1
Cardiac Arrest
1
1
Fall
1
1
Hypoxia
1
1
Pain
1
1
Scar Tissue
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
BRAEMAR, INC.
II
Jul-02-2013
2
BRAEMAR, INC.
II
Jul-02-2013
3
Boston Scientific Corporation
II
Sep-13-2017
4
Nihon Kohden America Inc
II
Mar-02-2021
5
Philips Visicu
II
Apr-04-2017
6
Philips Visicu
II
Apr-22-2016
7
Vitalconnect Inc.
II
Jul-10-2020
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