inforMED
MalfunctionFRI

MOBILE SCALE W/HANDRAIL, NA_PCORD

Received Nov 28, 2024 · Event occurred Nov 27, 2024

Report 1316463-2024-00159 · MDR key 20805526

Device

Generic name

Scale, Stand-on, Patient

Manufacturer

Welch Allyn Inc

Model number

5002-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 FOR MODEL 5122, UP TO 880 POUNDS 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 WAS PROVIDED THE PART # FOR A REPLACEMENT POWER CORD. ALTHOUGH THERE WAS NO REPORTED INJURY WITH THIS EVENT, IF THE REPORT OF A DAMAGED POWER CORD WITH EXPOSED WIRES WERE TO RECUR, IT COULD POTENTIALLY CAUSE SERIOUS INJURY OR DEATH. THEREFORE BAXTER IS REPORTING THIS EVENT.

Description of Event or Problem

CUSTOMER REPORTED THE POWER CORD HAD EXPOSED WIRES. THIS INCIDENT WAS CAPTURED UNDER COMPLAINT REF # (B)(4).