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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 44 44

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Alarm 59 59
Device Alarm System 24 24
Break 8 8
Defective Alarm 7 7
Delayed Alarm 5 5
Defective Device 4 4
Communication or Transmission Problem 3 3
Insufficient Information 3 3
Unstable 2 2
Defective Component 2 2
Failure to Sense 2 2
Patient Device Interaction Problem 2 2
Battery Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Device Sensing Problem 2 2
Disconnection 1 1
Off-Label Use 1 1
Patient-Device Incompatibility 1 1
Device Fell 1 1
Use of Device Problem 1 1
Component Missing 1 1
False Alarm 1 1
Detachment of Device or Device Component 1 1
Product Quality Problem 1 1
Computer Software Problem 1 1
Excessive Heating 1 1
Appropriate Term/Code Not Available 1 1
Intermittent Continuity 1 1
Connection Problem 1 1
Overheating of Device 1 1
Intermittent Communication Failure 1 1
Intermittent Loss of Power 1 1
Loose or Intermittent Connection 1 1
Loss of Power 1 1
Premature Discharge of Battery 1 1
No Device Output 1 1
Biocompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 65 65
Fall 29 29
Insufficient Information 15 15
Bone Fracture(s) 8 8
No Consequences Or Impact To Patient 8 8
No Known Impact Or Consequence To Patient 7 7
Head Injury 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Intracranial Hemorrhage 2 2
Laceration(s) 2 2
Skin Tears 2 2
Superficial (First Degree) Burn 1 1
Hypersensitivity/Allergic reaction 1 1
Unspecified Gastrointestinal Problem 1 1
Blood Loss 1 1
Abrasion 1 1
Blister 1 1
Localized Skin Lesion 1 1
Cardiac Arrest 1 1
Injury 1 1
Foreign Body In Patient 1 1
Swelling 1 1
Vomiting 1 1
Discomfort 1 1
Depression 1 1
Peeling 1 1
Fluid Discharge 1 1
Anxiety 1 1
Facial Nerve Paralysis 1 1
Hemorrhage, Subarachnoid 1 1
Hemorrhage/Bleeding 1 1
Pressure Sores 1 1
Distress 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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