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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

MDR Year MDR Reports MDR Events
2017 30 30
2018 28 28
2019 14 14
2020 17 17
2021 14 14
2022 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Alarm 31 31
Device Alarm System 29 29
Delayed Alarm 7 7
Defective Alarm 7 7
Adverse Event Without Identified Device or Use Problem 5 5
Device Operates Differently Than Expected 4 4
Communication or Transmission Problem 4 4
Failure to Sense 4 4
Device Operational Issue 3 3
Defective Component 3 3
Defective Device 3 3
Insufficient Information 2 2
Connection Problem 2 2
Smoking 2 2
Break 2 2
Computer Software Problem 1 1
Intermittent Continuity 1 1
Disconnection 1 1
Device Emits Odor 1 1
No Device Output 1 1
Overheating of Device 1 1
Product Quality Problem 1 1
Device Slipped 1 1
Alarm Not Visible 1 1
Premature Discharge of Battery 1 1
False Alarm 1 1
Device Inoperable 1 1
Use of Device Problem 1 1
Detachment of Device or Device Component 1 1
Intermittent Communication Failure 1 1
Device Sensing Problem 1 1
Device Displays Incorrect Message 1 1
Patient-Device Incompatibility 1 1
Biocompatibility 1 1
Component Missing 1 1
Device Issue 1 1
Incorrect Or Inadequate Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fall 49 50
No Known Impact Or Consequence To Patient 24 24
No Clinical Signs, Symptoms or Conditions 12 12
No Consequences Or Impact To Patient 12 12
Injury 5 5
Bone Fracture(s) 5 5
Head Injury 4 4
Hemorrhage/Bleeding 3 3
Insufficient Information 3 3
No Information 2 2
Skin Tears 2 2
Hemorrhage, Subarachnoid 2 2
Pressure Sores 2 2
Hip Fracture 1 1
Peeling 1 1
Swelling 1 1
Intracranial Hemorrhage 1 1
Hematoma 1 1
Abrasion 1 1
Contusion 1 1
Death 1 1
Facial Nerve Paralysis 1 1
Confusion/ Disorientation 1 1
Blood Loss 1 1
Superficial (First Degree) Burn 1 1
Fluid Discharge 1 1
No Code Available 1 1
Blister 1 1
Localized Skin Lesion 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Hill-Rom Inc. II Mar-22-2020
2 Stanley Security Solutions Inc II May-15-2019
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