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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
Regulation Description Bed-patient monitor.
Product CodeKMI
Regulation Number 880.2400
Device Class 1

MDR Year MDR Reports MDR Events
2020 17 17
2021 14 14
2022 21 21
2023 35 35
2024 69 69
2025 74 74

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Alarm 103 103
Device Alarm System 21 21
Break 20 20
Material Separation 12 12
Defective Alarm 9 9
Adverse Event Without Identified Device or Use Problem 8 8
Intermittent Loss of Power 5 5
Delayed Alarm 5 5
Defective Device 4 4
Communication or Transmission Problem 3 3
Insufficient Information 3 3
Unstable 2 2
Material Split, Cut or Torn 2 2
Loss of Power 2 2
Overheating of Device 2 2
Smoking 2 2
Defective Component 2 2
Patient Device Interaction Problem 2 2
Battery Problem 2 2
Use of Device Problem 2 2
Excessive Heating 2 2
Biocompatibility 1 1
No Device Output 1 1
Loose or Intermittent Connection 1 1
Electrical /Electronic Property Problem 1 1
Premature Discharge of Battery 1 1
Connection Problem 1 1
Melted 1 1
Intermittent Continuity 1 1
Appropriate Term/Code Not Available 1 1
Computer Software Problem 1 1
Device Sensing Problem 1 1
Detachment of Device or Device Component 1 1
Product Quality Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1
False Alarm 1 1
Component Missing 1 1
Electrical Overstress 1 1
Failure to Sense 1 1
Device Fell 1 1
Patient-Device Incompatibility 1 1
Crack 1 1
Physical Resistance/Sticking 1 1
Sensing Intermittently 1 1
Off-Label Use 1 1
Disconnection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 129 129
Insufficient Information 30 30
Fall 30 30
Bone Fracture(s) 8 8
Laceration(s) 7 7
Head Injury 5 5
No Known Impact Or Consequence To Patient 4 4
Pressure Sores 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Abrasion 3 3
Skin Tears 3 3
Intracranial Hemorrhage 2 2
No Consequences Or Impact To Patient 2 2
Bruise/Contusion 2 2
Superficial (First Degree) Burn 1 1
Hypersensitivity/Allergic reaction 1 1
Unspecified Gastrointestinal Problem 1 1
Hematoma 1 1
Blood Loss 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
Physical Entrapment 1 1
Fluid Discharge 1 1
Anxiety 1 1
Hemorrhage/Bleeding 1 1
Distress 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Hill-Rom Inc. II Mar-22-2020
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