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TPLC
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Device
monitor, bed patient
Product Code
KMI
Regulation Number
880.2400
Device Class
1
Premarket Reviews
Manufacturer
Decision
AFRAME DIGITAL, INC.
SUBSTANTIALLY EQUIVALENT
1
CENTAURI MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
INTEL-GE CARE INNOVATIONS LLC
SUBSTANTIALLY EQUIVALENT
1
LEAF HEALTHCARE, INC.
SUBSTANTIALLY EQUIVALENT
1
WIRELESS MEDCARE, LLC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
358
358
2015
34
34
2016
24
24
2017
30
30
2018
28
28
2019
14
14
2020
17
17
2021
14
14
2022
21
21
2023
35
35
2024
14
14
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Alarm System
174
174
No Audible Alarm
96
96
Device Operates Differently Than Expected
28
28
Loose or Intermittent Connection
26
26
Loss of Power
18
18
Defective Alarm
16
16
Insufficient Information
16
16
Failure to Power Up
15
15
Improper Alarm
15
15
Fitting Problem
15
15
False Alarm
13
13
Break
13
13
Device Issue
12
12
Device Stops Intermittently
11
11
Delayed Alarm
10
10
Adverse Event Without Identified Device or Use Problem
10
10
Component Missing
8
8
Device Displays Incorrect Message
8
8
Component Falling
7
7
Device Slipped
6
6
Device Inoperable
6
6
Battery Problem
6
6
Communication or Transmission Problem
6
6
Connection Problem
6
6
Device Operational Issue
6
6
Device Sensing Problem
5
5
Power Problem
5
5
Inaudible or Unclear Audible Prompt/Feedback
5
5
Failure to Sense
5
5
Alarm Not Visible
4
4
Defective Device
4
4
Fail-Safe Problem
4
4
Device Damaged Prior to Use
3
3
Defective Component
3
3
Improper or Incorrect Procedure or Method
3
3
Intermittent Continuity
3
3
Appropriate Term/Code Not Available
3
3
Detachment Of Device Component
2
2
Smoking
2
2
Unstable
2
2
Use of Device Problem
2
2
Mechanical Problem
2
2
Device Emits Odor
2
2
No Audible Prompt/Feedback
2
2
Patient Device Interaction Problem
2
2
Device Fell
1
1
Intermittent Loss of Power
1
1
Excessive Heating
1
1
Intermittent Communication Failure
1
1
Physical Property Issue
1
1
Device Dislodged or Dislocated
1
1
Environmental Compatibility Problem
1
1
Detachment of Device or Device Component
1
1
Inappropriate or Unexpected Reset
1
1
Unknown (for use when the device problem is not known)
1
1
Visual Prompts will not Clear
1
1
Invalid Sensing
1
1
Incorrect Or Inadequate Test Results
1
1
Decreased Sensitivity
1
1
Biocompatibility
1
1
Malposition of Device
1
1
Patient-Device Incompatibility
1
1
No Device Output
1
1
Overheating of Device
1
1
Off-Label Use
1
1
Product Quality Problem
1
1
Self-Activation or Keying
1
1
Under-Sensing
1
1
Sticking
1
1
Computer Software Problem
1
1
Crack
1
1
Disconnection
1
1
Electrical /Electronic Property Problem
1
1
Premature Discharge of Battery
1
1
Bent
1
1
Low Audible Alarm
1
1
Noise, Audible
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
164
164
No Known Impact Or Consequence To Patient
156
156
Fall
86
87
No Patient Involvement
84
84
No Clinical Signs, Symptoms or Conditions
47
47
Bone Fracture(s)
11
11
Not Applicable
10
10
Insufficient Information
9
9
Head Injury
7
7
Injury
6
6
Hip Fracture
6
6
Skin Tears
5
5
No Information
5
5
No Patient involvement
3
3
Hemorrhage/Bleeding
3
3
Pain
3
3
Intracranial Hemorrhage
2
2
Hemorrhage, Subarachnoid
2
2
Hematoma
2
2
Abrasion
2
2
Bruise/Contusion
2
2
Contusion
2
2
Death
2
2
Pressure Sores
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
No Code Available
1
1
Unspecified Gastrointestinal Problem
1
1
Blister
1
1
Localized Skin Lesion
1
1
Anxiety
1
1
Distress
1
1
Discomfort
1
1
Fracture, Arm
1
1
Depression
1
1
Loss of consciousness
1
1
Suture Abrasion
1
1
Superficial (First Degree) Burn
1
1
Fluid Discharge
1
1
Foreign Body In Patient
1
1
Ambulation Difficulties
1
1
Confusion/ Disorientation
1
1
Blood Loss
1
1
Facial Nerve Paralysis
1
1
Cardiac Arrest
1
1
Hypersensitivity/Allergic reaction
1
1
Laceration(s)
1
1
Peeling
1
1
Swelling
1
1
Vomiting
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
AliMed Corporation
II
Apr-16-2010
2
Curbell Medical, Inc.
II
Aug-26-2014
3
Hill-Rom Inc.
II
Mar-22-2020
4
Intel-GE Care Innovations LLC
II
Feb-23-2013
5
RF Technologies, Inc.
II
Jun-26-2013
6
Richard Wolf Medical Instruments Corp.
II
Mar-03-2015
7
Stanley Security Solutions Inc
II
May-15-2019
8
Stanley Security Solutions, Inc.
II
Sep-28-2012
9
Stanley Security Solutions, Inc.
II
Apr-28-2012
10
Stanley Security Solutions, Inc.
II
Apr-27-2012
11
Stanley Security Solutions, Inc.
II
Mar-31-2011
12
Stanley Security Solutions, Inc.
II
Jul-01-2010
13
Sterilmed Inc
II
Jan-13-2009
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