inforMED
MalfunctionBZG

CONTRACT EQ MM-HSCRIBE-DICOM MIDDLEWARE

Received May 15, 2026 · Event occurred Apr 20, 2026

Report 1316463-2026-00038 · MDR key 25191241

Device

Generic name

Spirometer, Diagnostic

Manufacturer

Welch Allyn Inc

Model number

CPWS-HL7

Product problems

  • Patient Data Problem

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

THE CAUSE OF THE REPORTED ISSUE IS YET TO BE IDENTIFIED. THE INVESTIGATION IS STILL ONGOING REGARDING THE REPORTED INCIDENT, A FINAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

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).