inforMED
MalfunctionFRI

6002 WHLCHR SCALE, NA_PCORD

Received Oct 27, 2025 · Event occurred Oct 6, 2025

Report 1316463-2025-00087 · MDR key 23393612

Device

Generic name

Scale, Stand-on, Patient

Manufacturer

Welch Allyn Inc

Model number

6002-XX-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

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.

Description of Event or Problem

CUSTOMER REPORTED THE SCALE HAS A POWER CORD THAT IS FRAYED WITH THE COPPER EXPOSED.