OtherGWL
SANDMAN DIGITAL 20 (SD20)
Received May 16, 2008 · Event occurred Apr 16, 2008
Report 9680138-2008-00001_2 · MDR key 1051497
Device
Generic name
*
Manufacturer
Eb Neuro SpaModel number
SD20 AMPL/HEADBOXCatalog number
D.2118/D.2120
Lot number
*
Product problems
- Unknown (for use when the device problem is not known)
Patient
*
- Tingling
- Burn, Thermal
- Electric Shock
- Treatment with medication(s)
Narrative
Description of Event or Problem
NELLCOR PURITAN BENNETT RECEIVED A REPORT FROM A SLEEP FACILITY THAT "A PT COMPLAINED OF SHOCKING FEELING THAT OCCURRED WHEN THE CUSTOMER CONNECTED THE PT HEADBOX TO THE HEADBOX CABLE. LATER, THAT EVENING THE PT COMPLAINED OF A TINGLING FEELING FROM THE ISO GROUND LEAD", BUT CONTINUED WITH THE STUDY THROUGHOUT THE NIGHT. IN THE MORNING, THE SLEEP FACILITY FURTHER REPORTED THAT THE PT COMPLAINED OF A BURN WHERE ONE OF THE LEADS HAD BEEN CONNECTED. THE PT WAS REFERRED TO AND TREATED BY A DERMATOLOGIST WHO PRESCRIBED ANTIBIOTIC CREAM.