MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL LTD PORTEX; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Model Number 370900-NL

Device Problems Decrease in Pressure (1490); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/04/2022

Event Type  malfunction  

Event Description

Disposable anesthesia breathing circuit failed compliance tests multiple times after using 3 circuits from same lot number.When manual leak test performed, circuit would only hold pressure if apl was set to 40cmh2o or greater.When circuit was released below 40cmh2o breathing circuit would not remain pressurized.

• Brand Name: PORTEX
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL LTD; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 13994664
• MDR Text Key: 288502569
• Report Number: 13994664
• Device Sequence Number: 1
• Product Code: CAI
• UDI-Device Identifier: 15019315076169
• UDI-Public: (01)15019315076169
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 370900-NL
• Device Lot Number: 4172906
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/07/2022
• Event Location: Hospital
• Date Report to Manufacturer: 04/04/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1