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TPLC
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Device
monitor, carbon-dioxide, cutaneous
Product Code
LKD
Regulation Number
868.2480
Device Class
2
Premarket Reviews
Manufacturer
Decision
PERIMED AB
SUBSTANTIALLY EQUIVALENT
1
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN
SUBSTANTIALLY EQUIVALENT
1
RADIOMETER MEDICAL APS
SUBSTANTIALLY EQUIVALENT
1
SENTEC AG
SUBSTANTIALLY EQUIVALENT
3
MDR Year
MDR Reports
MDR Events
2014
21
21
2015
20
20
2016
4
4
2019
3
3
2020
6
6
2021
2
2
2023
1
1
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
19
19
Insufficient Information
9
9
Fracture
5
5
Improper or Incorrect Procedure or Method
4
4
Material Deformation
3
3
Device Alarm System
3
3
Use of Device Problem
3
3
Break
2
2
Entrapment of Device
2
2
Malposition of Device
2
2
Positioning Problem
1
1
Smoking
1
1
Device Handling Problem
1
1
Calibration Problem
1
1
Electrical /Electronic Property Problem
1
1
Device Displays Incorrect Message
1
1
Failure to Disconnect
1
1
Fire
1
1
Off-Label Use
1
1
Thermal Decomposition of Device
1
1
Out-Of-Box Failure
1
1
Incorrect Measurement
1
1
Sticking
1
1
Device Operates Differently Than Expected
1
1
Device Dislodged or Dislocated
1
1
High Readings
1
1
Patient Device Interaction Problem
1
1
Difficult to Remove
1
1
Failure to Align
1
1
Detachment Of Device Component
1
1
Noise, Audible
1
1
Temperature Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Burn(s)
18
18
Injury
15
15
Partial thickness (Second Degree) Burn
13
13
No Known Impact Or Consequence To Patient
11
11
No Code Available
5
5
Apnea
4
4
No Information
4
4
No Clinical Signs, Symptoms or Conditions
3
3
Burning Sensation
3
3
Discomfort
3
3
Unspecified Infection
2
2
Burn, Thermal
2
2
Bacterial Infection
2
2
Failure of Implant
1
1
Localized Skin Lesion
1
1
Staphylococcus Aureus
1
1
No Patient Involvement
1
1
Insufficient Information
1
1
No Consequences Or Impact To Patient
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Philips Healthcare Inc.
II
Apr-08-2010
2
Philips Medical Systems, Inc.
II
Jan-16-2015
3
Radiometer America Inc
II
May-02-2016
4
Radiometer America Inc
II
Aug-19-2015
5
Radiometer America Inc
II
Dec-01-2011
6
Radiometer Medical ApS
II
Apr-22-2020
7
SenTec AG
II
Sep-15-2023
8
SenTec AG
II
Jun-20-2023
9
SenTec AG
II
Oct-28-2022
10
SenTec AG
II
Feb-18-2021
11
SenTec AG
II
Aug-05-2019
12
SenTec AG
II
Oct-17-2016
13
SenTec AG
II
Apr-22-2015
14
Sentec AG
II
Nov-22-2012
15
Sentec AG
II
Aug-13-2012
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