Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 electrocardiograph, ambulatory (without analysis)
Product CodeMWJ
Regulation Number 870.2800
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOTRICITY
  SUBSTANTIALLY EQUIVALENT 2
MEDICALGORITHMICS S.A.
  SUBSTANTIALLY EQUIVALENT 1
SPACELABS HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2019 4 4
2020 12 12
2021 3 3
2022 6 6
2023 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 5 5
Overheating of Device 4 4
Temperature Problem 4 4
Data Problem 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Therapeutic or Diagnostic Output Failure 2 2
Insufficient Information 2 2
Computer Operating System Problem 2 2
Device Sensing Problem 2 2
Display or Visual Feedback Problem 2 2
Fluid/Blood Leak 2 2
Disconnection 1 1
No Display/Image 1 1
Improper Chemical Reaction 1 1
Inappropriate or Unexpected Reset 1 1
Product Quality Problem 1 1
Material Too Rigid or Stiff 1 1
Telemetry Discrepancy 1 1
Use of Device Problem 1 1
Visual Prompts will not Clear 1 1
Date/Time-Related Software Problem 1 1
Defective Device 1 1
Wireless Communication Problem 1 1
Patient Device Interaction Problem 1 1
Output Problem 1 1
Power Problem 1 1
Problem with Software Installation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 9 9
No Clinical Signs, Symptoms or Conditions 7 7
Insufficient Information 6 6
No Information 4 4
Skin Inflammation/ Irritation 1 1
Hypersensitivity/Allergic reaction 1 1
Skin Irritation 1 1
Burning Sensation 1 1
Burn(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Braemar Manufacturing, LLC II Mar-10-2020
2 Philips North America, LLC II Feb-21-2020
-
-