MAUDE Adverse Event Report: CAREFUSION VITAL SIGNS; ADULT BREATHING CIRCUIT

Catalog Number 85438

Device Problems Device Operates Differently Than Expected (2913); Improper Flow or Infusion (2954)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/14/2018

Event Type  malfunction  

Event Description

As the operating room was being setup and equipment tested, the elbow with the "gas sampling line" port on the breathing circuit does not have a hole in it for flow.It is closed.Therefore, the device would not function properly for anesthesia.

• Brand Name: VITAL SIGNS
• Type of Device: ADULT BREATHING CIRCUIT
• Manufacturer (Section D): CAREFUSION; 22745 savi ranch parkway; yorba linda CA 92887
• MDR Report Key: 7424900
• MDR Text Key: 105266033
• Report Number: 7424900
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/20/2018,03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 85438
• Device Lot Number: 0001190545
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/20/2018
• Event Location: Hospital
• Date Report to Manufacturer: 03/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1