inforMED
MalfunctionIPF

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 Medical

Model number

RS 4I PLUS

Catalog 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