OtherGWL
MDR event
Received May 16, 2008
Report 9617286-2008-00001 · MDR key 1051500
Device
Product problems
- Unknown (for use when the device problem is not known)
Patient
Not reported
- Tingling
- Burn, Thermal
- Electric Shock
- Treatment with medication(s)
Narrative
Additional Manufacturer Narrative
THE SD20 IS COMPRISED OF A HEADBOX UNIT (CAT# D.2120) AND AMPLIFIER UNIT (CAT# D. 2118). THIS IS THEN INTEGRATED WITH OTHER COMPONENTS BY NELLCOR/COVIDIEN TO CREATE A COMPLETE SLEEP DIAGNOSTIC SYSTEM. EB NEURO IS THE MFR OF THE SD20, WHICH IS BELIEVED TO BE THE SOURCE OF THE EVENT. AN INVESTIGATION OF THE DEVICE IS UNDERWAY. WHEN THE INVESTIGATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.