inforMED
MalfunctionDSA

AMC 5 LEAD DISPOSABLE DIN TO PINCH

Received Aug 17, 2023 · Event occurred Aug 15, 2023

Report 17563169 · MDR key 17563169

Device

Generic name

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

Model number

LWM-329DS50/5A

Lot number

AE220707-B

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

CVOR (CARDIOVASCULAR OPERATING ROOM): DURING PROCEDURE, AMD 5 LEAD CABLES WERE DIFFICULT TO ATTACH. CONNECTION WAS TIGHT INTO THE MAIN ECG CABLE. ECG WORKED FOR A SHORT TIME, THEN THE V LEAD DID NOT WORK. IT WOULD RETURN INTERMITTENTLY. ANOTHER CABLE USED WITHOUT FURTHER PROBLEMS. NO KNOWN HARM TO PATIENT, MINOR DELAY IN PROCEDURE. MANUFACTURER RESPONSE FOR CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR), AMC (PER SITE REPORTER), WILL OBTAIN.