inforMED
MalfunctionDXN

MEDLINE

Received Jul 15, 2026 · Event occurred Jun 11, 2026

Report 1417592-2026-05892 · MDR key 25829440

Device

Generic name

Economy Digital Bp, Universal Cuff

Catalog number

MDSBPECON

Product problems

  • Image Display Error/Artifact

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

THE REPORT STATES THAT THERE WERE DEFECTIVE DEVICES RETURNED BY PATIENTS. DUE DILIGENCE HAS BEEN COMPLETED. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE CUSTOMER CONTACT WAS UNABLE OR UNWILLING TO PROVIDE FURTHER INCIDENT DETAILS TO THE MANUFACTURER. THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW UP CARE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

Description of Event or Problem

THE REPORT STATES THAT THERE WERE DEFECTIVE DEVICES RETURNED BY PATIENTS.