EMC MDQS Page 16
[Previous Page] [Table Of Contents] [Next Page]
GUIDE TO INSPECTIONS OF ELECTROMAGNETIC
COMPATIBILITY ASPECTS OF MEDICAL DEVICE
QUALITY SYSTEMS
MDR Search Terms that may indicate EMI events:
EMI
EMC
electromagnetic
ESD
electrostatic
static
surge
glitch
AC
power line
radio frequency or radiofrequency
radio wave or radiowave
susceptibility
immunity
interact
cellular phone
walkie talkie
mobile phone
false alarm
RFI
unexplained
noise
interfer…
lock-up or locks-up
MedWatch Coding for EMI Events (Form FDA 3500A):
Device Related Codes (block F10)
- 2345 EMI, (electromagnetic interference), compatibility/ incompatibility
- 1194 EMI, electromagnetic compatibility
- 2314 Radiofrequency interference (RFI)
- 1328 Interference with monitoring device
- 1329 Interference with pacemaker
Potential EMI Codes
- 1568 Failure of shielding
- 1012 Failure to alarm
- 1223 Intermittent failure
- 2163 Noise
Manufacturer Evaluation Codes (block H6)
- 197 Electromagnetic interference problem
- 198 Electrostatic interference
- 331 Environmental factors
[Previous Page] [Table Of Contents] [Next Page]
Return to: Page Top | Inspection Start