MAUDE Adverse Event Report: INTERSURGICAL UAB; BREATHING CIRCUIT

Model Number 2903000

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 10/10/2019

Event Type  Injury  

Manufacturer Narrative

The monitoring lines are assembled separately and 100% tested for leakage and occlusion.After assembling into the breathing system they are 100% tested for occlusion.No abnormalities found when reviewing the manufacturing records.No other similar report regarding this lot number have been received.Additional report to be provided when affected sample is received and investigated.

Event Description

The problem was discovered while administering 100% oxygen to a patient prior to inducing anaesthesia.Our gas analyser indicated that the expired oxygen concentration was only 46% after several minutes of giving 100% oxygen.I changed the breathing circuit, which solved the problem.

• Type of Device: BREATHING CIRCUIT
• Manufacturer (Section D): INTERSURGICAL UAB; arnioniu 60/28-1; pabrade, ; LH
• Manufacturer Contact: ivan seniut ; arnioniu 60/28-1; pabrade, vilniaus apskritis, lt-4710 ; LH
• MDR Report Key: 9510632
• MDR Text Key: 185714196
• Report Number: 1319447-2019-00003
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 2903000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 1 YR
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention