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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
44
44
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Alarm System
174
174
No Audible Alarm
118
118
Device Operates Differently Than Expected
28
28
Loose or Intermittent Connection
27
27
Loss of Power
18
18
Defective Alarm
16
16
Insufficient Information
16
16
Fitting Problem
15
15
Improper Alarm
15
15
Failure to Power Up
15
15
Break
14
14
False Alarm
13
13
Device Issue
12
12
Adverse Event Without Identified Device or Use Problem
12
12
Device Stops Intermittently
11
11
Delayed Alarm
10
10
Device Displays Incorrect Message
8
8
Component Missing
8
8
Battery Problem
8
8
Component Falling
7
7
Connection Problem
6
6
Device Inoperable
6
6
Device Operational Issue
6
6
Communication or Transmission Problem
6
6
Device Slipped
6
6
Failure to Sense
5
5
Inaudible or Unclear Audible Prompt/Feedback
5
5
Device Sensing Problem
5
5
Power Problem
5
5
Defective Device
4
4
Alarm Not Visible
4
4
Fail-Safe Problem
4
4
Improper or Incorrect Procedure or Method
3
3
Defective Component
3
3
Device Damaged Prior to Use
3
3
Appropriate Term/Code Not Available
3
3
Intermittent Continuity
3
3
Smoking
2
2
Patient Device Interaction Problem
2
2
Use of Device Problem
2
2
Detachment Of Device Component
2
2
No Audible Prompt/Feedback
2
2
Device Emits Odor
2
2
Mechanical Problem
2
2
Unstable
2
2
Premature Discharge of Battery
1
1
Intermittent Loss of Power
1
1
Unknown (for use when the device problem is not known)
1
1
Intermittent Communication Failure
1
1
Electrical /Electronic Property Problem
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
87
88
No Patient Involvement
84
84
No Clinical Signs, Symptoms or Conditions
65
65
Bone Fracture(s)
16
16
Insufficient Information
15
15
Not Applicable
10
10
Head Injury
7
7
Hip Fracture
6
6
Injury
6
6
No Information
5
5
Skin Tears
5
5
No Patient involvement
3
3
Hemorrhage/Bleeding
3
3
Pain
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Death
2
2
Bruise/Contusion
2
2
Pressure Sores
2
2
Hematoma
2
2
Abrasion
2
2
Hemorrhage, Subarachnoid
2
2
Contusion
2
2
Intracranial Hemorrhage
2
2
Laceration(s)
2
2
Ambulation Difficulties
1
1
Distress
1
1
Loss of consciousness
1
1
Facial Nerve Paralysis
1
1
Anxiety
1
1
Fluid Discharge
1
1
Peeling
1
1
Depression
1
1
Discomfort
1
1
Vomiting
1
1
Swelling
1
1
Foreign Body In Patient
1
1
Confusion/ Disorientation
1
1
Cardiac Arrest
1
1
Localized Skin Lesion
1
1
Blister
1
1
Blood Loss
1
1
Suture Abrasion
1
1
Unspecified Gastrointestinal Problem
1
1
No Code Available
1
1
Hypersensitivity/Allergic reaction
1
1
Superficial (First Degree) Burn
1
1
Fracture, Arm
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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