inforMED
MalfunctionCAI

VITAL SIGNS

Received Mar 20, 2025 · Event occurred Mar 7, 2025

Report 21652088 · MDR key 21652088

Device

Generic name

Circuit, Breathing (w Connector, Adaptor, Y Piece)

Model number

AXXXXX61

Catalog number

AXXXXX61

Lot number

0004304010

Patient

NA · Unknown

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

Narrative

Description of Event or Problem

ANESTHESIA CIRCUIT HAD A KNOT IN THE INTERNAL CO2 DETECTION TUBING. MANUFACTURER RESPONSE FOR CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE), VITAL SIGNS¿ (PER SITE REPORTER). FROM SUNMED, "WE HAVE RECEIVED 1 OTHER COMPLAINT FOR THIS ISSUE, COMPLAINT-[REDACTED], FROM [REDACTED]. THOSE ARE THE ONLY 2 COMPLAINTS FOR THE ISSUE IN THE PAST 2 YEARS. THE KNOT IS NOT A COMMON OCCURRENCE. HOWEVER, WE ARE IMPLEMENTING CORRECTIVE ACTION TO AVOID THIS DEFECT. A FIXTURE IS BEING INSTALLED IN THE ASSEMBLY PROCESS TO DETECT ANY KNOT IN THE TUBING AND HALT MANUFACTURING. THE FIXTURE IS BEING IMPLEMENTED IN CHANGE REQUEST #[REDACTED]."