RS 4I PLUS
Received Sep 13, 2024 · Event occurred Aug 8, 2024
Report 1644243-2024-00001 · MDR key 20213493
Device
Generic name
Rs 4i Plus Stimulator System
Manufacturer
Rs MedicalModel number
RS 4I PLUSCatalog number
950-0056-00
Product problems
- Smoking
- Smoking
Patient
54 YR · Male
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
SEE ATTACHED INVESTIGATION REPORT. MW5158485 ALSO ATTACHED.
Description of Event or Problem
PATIENT STATED THE CHARGER STARTED SMOKING. HE WAS CHARGING THE BATTERY WITH CHARGING DOCK AND AC ADAPTER PLUGGED INTO BATHROOM GFI OUTLET AND HE HEARD THE ALARM GOING OFF. HE WENT INSIDE THE BATHROOM AND NOTICED SMOKE COMING FROM AROUND THE BATTERY PACK, PRIMARILY. HE RIPPED THE CORD FROM THE WALL OUTLET AND THREW THE CHARGER AND CHARGING DOCK OUTSIDE. PATIENT DISPOSED OF THE CHARGER AND CHARGE DOCK. PATIENT STATED BATTERY PACK WAS IN THE CHARGING DOCK DURING THE INCIDENT BUT WAS UNSURE IF THE BATTERY PACK SUFFERED ANY SMOKE/FIRE DAMAGE. PATIENT ALSO STATED THE BATTERY AND THE DEVICE ARE FINE OTHER THAN THE BATTERY NEEDING TO BE CHARGED. HE INDICATED THAT HE WAS USING A RS MEDICAL CHARGE DOCK AND AC ADAPTER. HE STATED IT SEEMED LIKE AN ELECTRICAL SHORT AND THE GFI DID NOT POP. DATE OF THE OCCURRENCE WAS (B)(6) 2024 AND THE INCIDENT AWARE DATE WAS 12-AUG-2024
Remedial action
- Inspection
- Replace