GS300 W/CONTROL BOX, INTL DFU, NO CORD
Received Oct 4, 2024 · Event occurred Oct 1, 2024
Report 3006087789-2024-00003 · MDR key 20368188
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
INSPECTION OF THE DEVICE IS PENDING AND RESULTS WILL BE PROVIDED BY A FINAL REPORT.
Description of Event or Problem
CUSTOMER REPORTED THAT THE DEVICE HAS FALLEN APART AND WIRES ARE EXPOSED. THERE WERE NO INJURIES CAUSED BY THE REPORTED EVENT. THIS COMPLAINT WAS CAPTURED UNDER HILLROM REF # (B)(4).
Additional Manufacturer Narrative
THE WELCH ALLYN GS 300 IS AN EXAM LIGHT, 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 300 LIGHT IS MOUNTED ON A MOBILE STAND OR TABLE/WALL MOUNT. UPON INSPECTION, IT WAS DETERMINED THAT THE DEVICE HAD PHYSICAL DAMAGE WITH EXPOSED WIRES. 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 A EXPOSED WIRES IN THE DEVICE WERE TO RECUR, IT COULD POTENTIALLY CAUSE SERIOUS INJURY OR DEATH. THEREFORE BAXTER IS REPORTING THIS EVENT.
Description of Event or Problem
CUSTOMER REPORTED THAT THE DEVICE HAS FALLEN APART AND WIRES ARE EXPOSED. THERE WERE NO INJURIES CAUSED BY THE REPORTED EVENT. THIS COMPLAINT WAS CAPTURED UNDER HILLROM REF # (B)(4).