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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 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
Fitting Problem 15 15
Improper Alarm 15 15
Break 13 13
False Alarm 13 13
Device Issue 12 12
Device Stops Intermittently 11 11
Adverse Event Without Identified Device or Use Problem 10 10
Delayed Alarm 10 10
Device Displays Incorrect Message 8 8
Component Missing 8 8
Component Falling 7 7
Device Slipped 6 6
Connection Problem 6 6
Device Inoperable 6 6
Battery Problem 6 6
Device Operational Issue 6 6
Communication or Transmission Problem 6 6
Failure to Sense 5 5
Power Problem 5 5
Device Sensing Problem 5 5
Inaudible or Unclear Audible Prompt/Feedback 5 5
Alarm Not Visible 4 4
Defective Device 4 4
Fail-Safe Problem 4 4
Intermittent Continuity 3 3
Appropriate Term/Code Not Available 3 3
Defective Component 3 3
Improper or Incorrect Procedure or Method 3 3
Device Damaged Prior to Use 3 3
No Audible Prompt/Feedback 2 2
Mechanical Problem 2 2
Detachment Of Device Component 2 2
Patient Device Interaction Problem 2 2
Device Emits Odor 2 2
Unstable 2 2
Use of Device Problem 2 2
Smoking 2 2
Device Dislodged or Dislocated 1 1
Physical Property Issue 1 1
Unknown (for use when the device problem is not known) 1 1
Intermittent Communication Failure 1 1
Inappropriate or Unexpected Reset 1 1
Electrical /Electronic Property Problem 1 1
Premature Discharge of Battery 1 1
Decreased Sensitivity 1 1
Invalid Sensing 1 1
Self-Activation or Keying 1 1
Device Fell 1 1
Product Quality Problem 1 1
Bent 1 1
Visual Prompts will not Clear 1 1
Patient-Device Incompatibility 1 1
Off-Label Use 1 1
Intermittent Loss of Power 1 1
Environmental Compatibility Problem 1 1
Under-Sensing 1 1
Sticking 1 1
Excessive Heating 1 1
Crack 1 1
Low Audible Alarm 1 1
Detachment of Device or Device Component 1 1
Incorrect Or Inadequate Test Results 1 1
Overheating of Device 1 1
Noise, Audible 1 1
No Device Output 1 1
Biocompatibility 1 1
Disconnection 1 1
Malposition of Device 1 1
Computer Software 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 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
Hemorrhage/Bleeding 3 3
Pain 3 3
No Patient involvement 3 3
Hemorrhage, Subarachnoid 2 2
Pressure Sores 2 2
Bruise/Contusion 2 2
Hematoma 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Contusion 2 2
Death 2 2
Abrasion 2 2
Intracranial Hemorrhage 2 2
Swelling 1 1
Foreign Body In Patient 1 1
Confusion/ Disorientation 1 1
Localized Skin Lesion 1 1
No Code Available 1 1
Peeling 1 1
Superficial (First Degree) Burn 1 1
Anxiety 1 1
Laceration(s) 1 1
Facial Nerve Paralysis 1 1
Loss of consciousness 1 1
Hypersensitivity/Allergic reaction 1 1
Fluid Discharge 1 1
Ambulation Difficulties 1 1
Unspecified Gastrointestinal Problem 1 1
Fracture, Arm 1 1
Blood Loss 1 1
Suture Abrasion 1 1
Distress 1 1
Cardiac Arrest 1 1
Discomfort 1 1
Depression 1 1
Vomiting 1 1
Blister 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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