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

Model Number 002502

Device Problems Failure to Deliver (2338); No Pressure (2994)

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

Event Date 02/11/2019

Event Type  Injury  

Event 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
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): CAREFUSION CORPORATION; 22745 savi ranch parkway; yorba linda CA 92887
• MDR Report Key: 8526720
• MDR Text Key: 142330355
• Report Number: 8526720
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 10885403039249
• UDI-Public: (01)10885403039249(10)0001156378(17)220925
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 002502
• Device Catalogue Number: 002502
• Device Lot Number: 0001156378
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/03/2019
• Event Location: Hospital
• Date Report to Manufacturer: 04/18/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 22630 DA