• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Alarm 40 40
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
Patient Device Interaction Problem 2 2
Device Sensing Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Defective Component 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
Component Missing 1 1
Patient-Device Incompatibility 1 1
Biocompatibility 1 1
Connection Problem 1 1
Detachment of Device or Device Component 1 1
Device Fell 1 1
Intermittent Loss of Power 1 1
Excessive Heating 1 1
Intermittent Communication Failure 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 51 51
Fall 28 28
Insufficient Information 11 11
No Consequences Or Impact To Patient 8 8
No Known Impact Or Consequence To Patient 7 7
Bone Fracture(s) 3 3
Head Injury 3 3
Intracranial Hemorrhage 2 2
Skin Tears 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
Blood Loss 1 1
Superficial (First Degree) Burn 1 1
Fluid Discharge 1 1
Foreign Body In Patient 1 1
Pressure Sores 1 1
Anxiety 1 1
Distress 1 1
Discomfort 1 1
Injury 1 1
Depression 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

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