SIEMENS 3.0T TXRX 15 CH KNEE
Received Dec 20, 2011 · Event occurred Nov 16, 2011
Report 3007350713-2011-00002 · MDR key 2396550
Device
Generic name
Coil, Magnetic Resonance, Specialty
Manufacturer
Quality ElectrodynamicsModel number
Q7000008Catalog number
QED000008
Lot number
NA
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
UNK
- Superficial (First Degree) Burn
Narrative
Description of Event or Problem
CUSTOMER HAD BURNS ON KNEE (RED IRRITATED LOOK). NO OTHER ISSUES ON COIL DETECTED, BUT COIL EXCHANGED FOR SAFETY CONCERNS.
Additional Manufacturer Narrative
INVESTIGATION DETAILS: UPON RECEIVING THE COIL, NORMAL COIL CONFIDENCE TESTING WAS PERFORMED AND NO FAULT WAS FOUND. FURTHER INVESTIGATION FOUND THAT THE TUNING OF SEVERAL RECEIVE CHANNELS WAS OUTSIDE THE DATA SHEET SPECIFICATION. THE SOURCE OF THE ELEMENTS BEING OFF-TUNED WAS LINKED TO THE VARIABLE CAPACITORS ON EACH COIL ELEMENT. HOWEVER, BECAUSE THESE VARIABLE CAPACITORS ARE ALSO USED IN THE DECOUPLING CIRCUITS, WE PERFORMED TESTING TO CONFIRM AN OFF-TUNED DECOUPLING CIRCUIT DID NOT CONTRIBUTE TO THE REPORTED INCIDENT. SUMMARY: BASED ON THE TESTING PERFORMED, WE CONCLUDED THAT THE OFF-TUNED DECOUPLING CIRCUITS DID NOT CONTRIBUTE TO THE REPORTED INCIDENT.