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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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GUIDE TO INSPECTIONS OF ELECTROMAGNETIC

COMPATIBILITY ASPECTS OF MEDICAL DEVICE

QUALITY SYSTEMS

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APPENDIX D - MDR SEARCH TERMS AND MEDWATCH CODES

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

 

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