MAUDE Adverse Event Report: CAREFUSION 207, INC. DBA CAREFUSION BIRD AIR-OXYGEN BLENDER; MIXER, BREATHING GASES, ANESTHESIA INHALATION

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Respiratory Distress (2045)

Event Date 10/06/2015

Event Type  malfunction  

Event Description

Intubation attempted x 3 due to infant crying.Infant de-satted between attempts to mid 50's on blended 02 via positive pressure ventilation (ppv), t-piece changed for concern it was not working correctly and then replaced with a new one for concerns it was not functioning appropriately, pulse ox probe moved to arm.Infant was put on ventilator at 100% and sats 98 - 100%.When intubation attempted again, infant de-satted to low 60's.

• Brand Name: BIRD AIR-OXYGEN BLENDER
• Type of Device: MIXER, BREATHING GASES, ANESTHESIA INHALATION
• Manufacturer (Section D): CAREFUSION 207, INC. DBA CAREFUSION; 1100 bird center drive; palm springs CA 92262
• MDR Report Key: 5273074
• MDR Text Key: 32873830
• Report Number: 5273074
• Device Sequence Number: 1
• Product Code: BZR
• 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: 12/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/04/2015
• Event Location: Hospital
• Date Report to Manufacturer: 12/04/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/08/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Weight: 3