MAUDE Adverse Event Report: CAREFUSION/ VYAIRE MEDICAL, INC. CAREFUSION AIRLIFE MISTY MAX 10 NEBULIZER

Catalog Number 002445

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 12/17/2017

Event Type  Injury  

Event Description

Airlife misty mac 10 nebulizer failed to nebulize medication.

• Brand Name: CAREFUSION AIRLIFE MISTY MAX 10 NEBULIZER
• Type of Device: NEBULIZER
• Manufacturer (Section D): CAREFUSION/ VYAIRE MEDICAL, INC. ; yorba linda CA 92887
• MDR Report Key: 7128165
• MDR Text Key: 95363122
• Report Number: MW5074106
• 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: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 002445
• Device Lot Number: 0001151346
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Weight: 80