MAUDE Adverse Event Report: AEROGEN LTD. AEROGEN PRO-X CONTROLLER

Model Number AG-PX1050-US

Device Problem Fire (1245)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/27/2023

Event Type  malfunction  

Manufacturer Narrative

Aerogen have taken the appropriate measures to review and investigate the complaint received.Aerogen have requested return of the device from the reporting healthcare worker.A review per aerogen's 'field correction/removal procedure' was completed based on this complaint received which may pose a risk to patients.Based on the nature of the complaint, and current investigation in progress it has been concluded that no field correction or removal is required by aerogen at this time.This will be reviewed as investigation progresses and if any further information becomes available to aerogen which may impact the previous no fsca determination, the review and conclusion will be documented within the subsequent report.

Event Description

Controller charging port and power cable allegedly caught on fire during use, as reported by staff member.No patient injury reported.Complaints team are currently investigating.

Manufacturer Narrative

Aerogen have taken the appropriate measures to review and investigate the complaint received.Aerogen have requested return of the device from the reporting healthcare worker.A review per aerogen's 'field correction/removal procedure' was completed based on this complaint received which may pose a risk to patients.Based on the nature of the complaint, and current investigation in progress it has been concluded that no field correction or removal is required by aerogen at this time.This will be reviewed as investigation progresses and if any further information becomes available to aerogen which may impact the previous no fsca determination, the review and conclusion will be documented within the subsequent report.The device was received for investigation.Risk assessment.The primary conclusion to the risk assessment is that the complaint relates to user misuse of the pro-x controller.Based on the investigation completed, it has been determined that the controller was exposed to/submerged in liquid beyond what it is qualified to withstand.As documented in the instructions for use, when cleaning the controller, it is required to "wipe clean with an alcohol based disinfectant wipe", only.In addition to this, there is no evidence of fire to the controller, and there are a number of design controls which would prevent this from occurring.The most likely outcome of this based on review of risk documentation is "patient/user exposed to fire", which is an anticipated risk identified by aerogen for devices and has been appraised as part of dp008, risk management procedure.Based on the investigation completed, fuse functionality (f2 fuse) was confirmed to be working correctly, thus the 'fail-safe' design feature means there is a low risk to the patient based on clinical assessment.No evidence to date that any other pro-x controller(s) in the field are showing trends of a similar nature.Market feedback will continue to be monitored through the aerogen customer complaints process.No further action is required based on this risk assessment completed as per aerogen's risk management procedures and en iso14971 "application of risk management for medical devices".Based on the information received, there will be no new protective measures introduced or no new risks or additional harms being introduced because of this assessment.In addition, a review was completed per aerogen's 'field correction/removal procedure' (qp049, rev n), based on this complaint received.Based on the risk assessment completed above, aerogen concluded that the completion of a product assessment form is not warranted at this time due to the nature of the complaint.It has been concluded that no field correction or removal is required by aerogen at this time because of this assessment.

Event Description

Controller charging port and power cable allegedly caught on fire during use, as reported by staff member.No patient injury reported.Complaints team are currently investigating.

Event Description

Controller charging port and power cable allegedly caught on fire during use, as reported by staff member.No patient injury reported.Complaints team are currently investigating.

Manufacturer Narrative

Aerogen have taken the appropriate measures to review and investigate the complaint received.Aerogen have requested return of the device from the reporting healthcare worker.A review per aerogen's 'field correction/removal procedure' was completed based on this complaint received which may pose a risk to patients.Based on the nature of the complaint, and current investigation in progress it has been concluded that no field correction or removal is required by aerogen at this time.This will be reviewed as investigation progresses and if any further information becomes available to aerogen which may impact the previous no fsca determination, the review and conclusion will be documented within the subsequent report.The device was received for investigation.Risk assessment: the primary conclusion to the risk assessment is that the complaint relates to user misuse of the pro-x controller.Based on the investigation completed, it has been determined that the controller was exposed to/submerged in liquid beyond what it is qualified to withstand.As documented in the instructions for use, when cleaning the controller, it is required to "wipe clean with an alcohol based disinfectant wipe", only.In addition to this, there is no evidence of fire to the controller, and there are a number of design controls which would prevent this from occurring.The most likely outcome of this based on review of risk documentation is "patient/user exposed to fire", which is an anticipated risk identified by aerogen for devices and has been appraised as part of dp008, risk management procedure.Based on the investigation completed, fuse functionality (f2 fuse) was confirmed to be working correctly, thus the 'fail-safe' design feature means there is a low risk to the patient based on clinical assessment.No evidence to date that any other pro-x controller(s) in the field are showing trends of a similar nature.Market feedback will continue to be monitored through the aerogen customer complaints process.No further action is required based on this risk assessment completed as per aerogen's risk management procedures and en iso14971 "application of risk management for medical devices".Based on the information received, there will be no new protective measures introduced or no new risks or additional harms being introduced because of this assessment.In addition, a review was completed per aerogen's 'field correction/removal procedure' (qp049, rev n), based on this complaint received.Based on the risk assessment completed above, aerogen concluded that the completion of a product assessment form is not warranted at this time due to the nature of the complaint.It has been concluded that no field correction or removal is required by aerogen at this time because of this assessment.Update on the 30th of january 2024: follow up report 2 submitted for the addition of 510k number.

• Brand Name: AEROGEN PRO-X CONTROLLER
• Type of Device: AEROGEN PRO-X CONTROLLER
• Manufacturer (Section D): AEROGEN LTD.; galway buisness park; dangan; galway, H91EH 6C; EI H91EH6C
• Manufacturer (Section G): AEROGEN LTD.; galway buisness park; dangan; galway, H91EH 6C; EI H91EH6C
• Manufacturer Contact: andrea small ; galway buisness park; dangan; galway, H91EH-6C ; EI H91EH6C
• MDR Report Key: 17009064
• MDR Text Key: 315992928
• Report Number: 3003399703-2023-21591
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AG-PX1050-US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1