inforMED
MalfunctionBZG

SMARTCARE CONNECT PREMIUM PLUS - TIER D

Received Apr 1, 2026 · Event occurred Mar 3, 2026

Report 1316463-2026-00018 · MDR key 24757348

Device

Generic name

Spirometer, Diagnostic

Manufacturer

Welch Allyn Inc

Model number

CPWS

Product problems

  • Patient Data Problem

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

THE CUSTOMER REPORTED THAT INCORRECT REPORTS WERE AUTO ATTACHING TO THE WRONG PATIENT FILE. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #: (B)(4).

Additional Manufacturer Narrative

ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE REPORTED INCIDENT, A FINAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.