inforMED
MalfunctionDSA

CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

Received Aug 12, 2023

Report MW5136093 · MDR key 17529164

Device

Generic name

Cable, Transducer And Electrode, Patient, (including Connector)

Manufacturer

Unknown

Model number

4053 AND 4054

Product problems

  • Capturing Problem
  • Capturing Problem

Patient

Unknown

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

POSSIBLE RV OR RA LOSS OF CAPTURE (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).