MOBILE SCALE W/HANDRAIL, KG, NA_PCORD
Received Jul 12, 2024 · Event occurred Jun 25, 2024
Report 1316463-2024-00082 · MDR key 19731642
Device
Product problems
- Melted
- Material Split, Cut or Torn
- Melted
- Material Split, Cut or Torn
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT THE END PORTION OF THE POWER SUPPLY WAS MELTED AND COPPER WIRES WERE SHOWING. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT (B)(4).
Additional Manufacturer Narrative
THE WELCH ALLYN MASTED SCALES ARE INTENDED TO BE USED BY CLINICIANS FOR WEIGHING PATIENTS UP TO 660 POUNDS (300 KG) FOR MODEL 5122, UP TO 880 POUNDS (400 KG) FOR MODELS 5002 AND 6002. MASTED SCALES CAN MAKE CONTACT WITH A PATIENT¿S HANDS AND FEET. CONTACT DURATION IS INTENDED TO BE LIMITED TO LESS THAN 30 SECONDS. BAXTER RECEIVED PICTURES OF THE AFFECTED PART. UPON REMOTE INSPECTION, IT WAS DETERMINED THAT THE POWER CORD WAS DAMAGED WITH EXPOSED COPPER WIRES. A REPLACEMENT POWER SUPPLY 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 DAMAGED POWER SUPPLY WITH EXPOSED WIRES WERE TO RECUR, IT COULD POTENTIALLY CAUSE SERIOUS INJURY OR DEATH. THEREFORE BAXTER IS REPORTING THIS EVENT.