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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device monitor, bed patient
Product CodeKMI
Regulation Number 880.2400
Device Class 1


Premarket Reviews
ManufacturerDecision
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
Adverse Event Without Identified Device or Use Problem 12 12
Device Issue 12 12
Device Stops Intermittently 11 11
Delayed Alarm 10 10
Component Missing 8 8
Battery Problem 8 8
Device Displays Incorrect Message 8 8
Component Falling 7 7
Device Slipped 6 6
Communication or Transmission Problem 6 6
Device Inoperable 6 6
Device Operational Issue 6 6
Connection Problem 6 6
Inaudible or Unclear Audible Prompt/Feedback 5 5
Power Problem 5 5
Failure to Sense 5 5
Device Sensing Problem 5 5
Alarm Not Visible 4 4
Defective Device 4 4
Fail-Safe Problem 4 4
Appropriate Term/Code Not Available 3 3
Defective Component 3 3
Device Damaged Prior to Use 3 3
Improper or Incorrect Procedure or Method 3 3
Intermittent Continuity 3 3
Detachment Of Device Component 2 2
Device Emits Odor 2 2
Unstable 2 2
Mechanical Problem 2 2
No Audible Prompt/Feedback 2 2
Smoking 2 2
Patient Device Interaction Problem 2 2
Use of Device Problem 2 2
Biocompatibility 1 1
No Device Output 1 1
Disconnection 1 1
Noise, Audible 1 1
Overheating of Device 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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