MAUDE Adverse Event Report: CAREFUSION CORPORATION AIRLIFE; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number	002502
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/11/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
When the device was hooked to the flow meter, the pressure from the flow meter went to zero.Was not able to deliver medication ordered with this device.Device taken off and new one used.Kept faulty one for quality control review.

• Brand Name: AIRLIFE
• Common Device Name: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): CAREFUSION CORPORATION; 22745 savi ranch parkway; yorba linda CA 92887
• MDR Report Key: 8526720
• Report Number: 8526720
• Device Sequence Number: 1899851
• Product Code: CAF
• UDI-Device Identifier: 10885403039249
• UDI-Public: (01)10885403039249(10)0001156378(17)220925
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/03/2019
• Report Date (Section F): 04/03/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 002502
• Device Catalogue Number: 002502
• Device Lot Number: 0001156378
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/18/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Date Report Sent to FDA: 04/03/2019