3 .5V RCHG HANDLE F/DESK CHGR
Received Sep 21, 2023 · Event occurred Aug 9, 2023
Report 1316463-2023-00207 · MDR key 17787977
Device
Product problems
- Fire
- Overheating of Device
- Sparking
- Fire
- Overheating of Device
- Sparking
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE WELCH ALLYN PANOPTIC OPHTHALMOSCOPES ARE INTENDED TO BE USED BY CLINICIANS AND MEDICALLY QUALIFIED PERSONNEL FOR EXAMINATION OF THE RETINA, CORNEA, AQUEOUS, LENS AND VITREOUS OF THE EYE UNDER ILLUMINATION AND MAGNIFICATION ON PEDIATRIC AND ADULT PATIENTS. THE INTENDED USE ENVIRONMENTS FOR THE WELCH ALLYN PANOPTIC OPHTHALMOSCOPES ARE PROFESSIONAL HEALTHCARE FACILITY ENVIRONMENTS SUCH AS GENERAL PHYSICIAN'S OFFICES, HOSPITALS, SPECIALIST, URGENT CARE, CLINICS, AND CLINICAL ENVIRONMENT TRAINING. THE PART NUMBER ASSOCIATED WITH THE WELCH ALLYN 3.5 V RECHARGEABLE POWER HANDLE FOR DESK CHARGER; LITHIUM- ION BATTERY IS # 71960. THE CUSTOMER DECLINED TO RETURN THE DEVICE FOR INSPECTION, THEREFORE AN INVESTIGATION INTO THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE PERFORMED. ALTHOUGH THERE WAS NO INJURY REPORTED, IF THE REPORTED EVENT WERE TO RECUR AND THE DEVICE WERE TO SPARK AND PRODUCE A FLAME, IT COULD LEAD TO A SERIOUS INJURY OR DEATH. THEREFORE, HILLROM IS REPORTING THIS MALFUNCTION.
Description of Event or Problem
THE CUSTOMER REPORTED THAT THE OPHTHALMOSCOPE HANDLE WAS HOT AND PRODUCED SPARKS AND A SMALL FLAME WHEN THE UNIT WAS SWITCHED ON. THIS INCIDENT WAS CAPTURED UNDER HILLROM COMPLAINT REF # (B)(4).