GS 777 WALL TRANSFORMER US
Received Feb 20, 2025 · Event occurred Jan 31, 2025
Report 1316463-2025-00020 · MDR key 21419718
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 GS 777 WALL TRANSFORMER IS INTENDED TO PROVIDE POWER TO WELCH ALLYN 3.5V INSTRUMENTS. THE DEVICE POWERS TWO INSTRUMENT HANDLES, ONTO WHICH WELCH ALLYN 3.5V DIAGNOSTIC INSTRUMENT HEADS CAN BE ATTACHED. THESE DIAGNOSTIC INSTRUMENT HEADS INCLUDE THE WELCH ALLYN OTOSCOPE, OPTHALMOSCOPE AND EPISCOPE. THE WALL TRANSFORMER CAN BE USED ALONE, OR AS PART OF THE GS 777 INTEGRATED WALL SYSTEM (IWS), WHICH INCORPORATES OTHER WELCH ALLYN DEVICES, SUCH AS THE SURETEMP THERMOMETER, SPOT VITAL SIGNS MONITOR AND THE PROBP 3400 AND THE ANEROID BLOOD PRESSURE GAUGE. ALTHOUGH THE REPORTED EVENT DID NOT RESULT IN A SERIOUS INJURY, THE REPORT OF FRAYED POWER CORD COULD CONTRIBUTE TO A SERIOUS INJURY OR DEATH, IF THE MALFUNCTION WERE TO RECUR. THEREFORE, BAXTER CONSIDERS THIS COMPLAINT A REPORTABLE MALFUNCTION.
Description of Event or Problem
CUSTOMER REPORTED FRAYED CORD. THERE WAS NO ALLEGATION OF PATIENT OR CAREGIVER INJURY OR DEATH REPORTED FROM THIS ALLEGED INCIDENT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).