MAUDE Adverse Event Report: CAREFUSION 2200, INC. AIRLIFE; NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER)

Catalog Number 001268

Device Problems Detachment Of Device Component (1104); Loose or Intermittent Connection (1371)

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

Event Date 01/06/2017

Event Type  malfunction  

Event Description

Anesthesia removed bag from pediatric oxygen mask to attach oxygen tubing directly.Small phlange/disk on mask came loose, potential choking hazard.

• Brand Name: AIRLIFE
• Type of Device: NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER)
• Manufacturer (Section D): CAREFUSION 2200, INC.; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 6282480
• MDR Text Key: 65940567
• Report Number: 6282480
• Device Sequence Number: 1
• Product Code: CCQ
• 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: 01/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 001268
• Device Lot Number: 0000999487
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/17/2017
• Event Location: Hospital
• Date Report to Manufacturer: 01/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Age: 6 YR