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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
2019 14 14
2020 17 17
2021 14 14
2022 21 21
2023 35 35
2024 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Alarm 34 34
Device Alarm System 24 24
Defective Alarm 7 7
Break 6 6
Delayed Alarm 5 5
Defective Device 4 4
Communication or Transmission Problem 3 3
Insufficient Information 3 3
Defective Component 2 2
Patient Device Interaction Problem 2 2
Device Sensing Problem 2 2
Failure to Sense 2 2
Unstable 2 2
Use of Device Problem 1 1
Premature Discharge of Battery 1 1
False Alarm 1 1
Computer Software Problem 1 1
Intermittent Continuity 1 1
Disconnection 1 1
No Device Output 1 1
Overheating of Device 1 1
Loss of Power 1 1
Off-Label Use 1 1
Product Quality Problem 1 1
Device Fell 1 1
Excessive Heating 1 1
Intermittent Communication Failure 1 1
Component Missing 1 1
Patient-Device Incompatibility 1 1
Biocompatibility 1 1
Appropriate Term/Code Not Available 1 1
Connection Problem 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 46 46
Fall 28 28
No Consequences Or Impact To Patient 8 8
No Known Impact Or Consequence To Patient 7 7
Insufficient Information 7 7
Bone Fracture(s) 3 3
Head Injury 3 3
Intracranial Hemorrhage 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Abrasion 1 1
Cardiac Arrest 1 1
Facial Nerve Paralysis 1 1
Unspecified Gastrointestinal Problem 1 1
Blister 1 1
Localized Skin Lesion 1 1
Hemorrhage, Subarachnoid 1 1
Hypersensitivity/Allergic reaction 1 1
Laceration(s) 1 1
Peeling 1 1
Swelling 1 1
Vomiting 1 1
Hemorrhage/Bleeding 1 1
Pressure Sores 1 1
Anxiety 1 1
Distress 1 1
Discomfort 1 1
Injury 1 1
Depression 1 1
Blood Loss 1 1
Superficial (First Degree) Burn 1 1
Fluid Discharge 1 1
Foreign Body In Patient 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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