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 monitor, heart rate, fetal, ultrasonic
Product CodeHEL
Regulation Number 884.2660
Device Class 2

MDR Year MDR Reports MDR Events
2015 1 1
2018 2 2
2019 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Material Integrity Problem 5 5
No Apparent Adverse Event 3 3
Operating System Becomes Nonfunctional 2 2
Break 2 2
Crack 2 2
Calibration Problem 2 2
Communication or Transmission Problem 1 1
Device Operates Differently Than Expected 1 1
Electrical Shorting 1 1
Device Stops Intermittently 1 1
Detachment Of Device Component 1 1
Component Falling 1 1
Noise, Audible 1 1
No Audible Alarm 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 4 4
No Patient Involvement 2 2
No Code Available 2 2
No Known Impact Or Consequence To Patient 1 1

-
-