inforMED
MalfunctionFRI

5002-KX-B

Received Dec 2, 2025 · Event occurred Nov 10, 2025

Report 1316463-2025-00093 · MDR key 23696721

Device

Generic name

Scale, Stand-on, Patient

Manufacturer

Welch Allyn, Inc.

Model number

901109

Catalog number

5002-KX-B

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

Description of Event or Problem

CUSTOMER REPORTED POWER SUPPLY HAD EXPOSED WIRING. THERE WAS NO ADVERSE EVENT REPORTED.

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. THE CUSTOMER REFUSED TO RETURN THE DEVICE AND WAS PROVIDED WITH THE REPLACEMENT PART #S TO RESOLVE THE MALFUNCTION. CONTACT WITH EXPOSED ELECTRICAL WIRE CAN RESULT IN ELECTRICAL INJURY.