EXAM LT IV LED W/TABLE/WALL MOUNT DOM
Received Mar 11, 2025 · Event occurred Feb 14, 2025
Report 1316463-2025-00024 · MDR key 21576758
Device
Product problems
- Material Split, Cut or Torn
- Material Split, Cut or Torn
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE WELCH ALLYN GS EXAM LIGHT IV IS DESIGNED TO MEET THE VARIOUS NEEDS OF THE PHYSICIAN¿S OFFICE, HOSPITAL ENVIRONMENT AND SPECIALIST¿S OFFICE. IT IS NOT INTENDED FOR RENDERING DIAGNOSIS OR SURGERY. THE GS EXAM LIGHT IV LIGHT IS MOUNTED ON A MOBILE STAND OR TABLE/WALL MOUNT. A REPLACEMENT OF THE DEVICE WAS SENT TO THE CUSTOMER. BASED ON THIS INFORMATION, NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. ALTHOUGH THERE WAS NO REPORTED INJURY WITH THIS EVENT, IF THE REPORT OF EXPOSED WIRING WERE TO RECUR, IT COULD POTENTIALLY CAUSE SERIOUS INJURY OR DEATH. THEREFORE, BAXTER IS REPORTING THIS EVENT.
Description of Event or Problem
CUSTOMER REPORTED EXPOSED WIRING AND DEVICE NOT TURNING ON. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #: (B)(4).