MAUDE Adverse Event Report: ACTEGY LTD AEROSURE MEDIC; ELECTRONIC RESPIRATORY MUSCLE TRAINER

Model Number AEROSURE MEDIC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Sudden Cardiac Death (2510)

Event Date 04/11/2016

Event Type  Death  

Manufacturer Narrative

Results of manufacturer's final investigation (final report): manufacturer's device analysis results: multiple attempts have been made (13/04/16, 18/04/16, 19/04/16, 05/05/16, 31/05/16, 01/06/16 and 14/06/16) to retrieve the device and obtain the necessary information to complete investigation.Information has not been forthcoming and device has not been returned.Unable to complete investigation.This case has been closed as devices applicable to this incident.There have been no other incidents reported to the manufacturer which would suggest that there was any product malfunctions associated with this lot of devices.Remedial action/corrective action/preventive action: no action taken as unable to establish root cause.Most likely root cause is existing underlying patient condition.As this is an isolated incident, we do not consider it to be necessary to amend any warnings or labelling of the device.No other actions are deemed necessary at this time.Manufacturer's final comments: insufficient information available to definitively link the use of the aerosure device with the adverse event.Review of the manufacturing and post market history for the aerosure lot do not indicate any issues with the specific lot of aerosure devices.Due to the limited available information, a complete medical review could not take place.Rather, the information provided by the patient's daughter on the 12/04/16 and information provided by patient at time of purchase was reviewed by dr (b)(6) ma (cantab), mb, bchir, mrcp, ffpm baxter medical ltd to determine the likely involvement of the aerosure device in the incident.The preliminary view of medical advisor confirms that there is insufficient information to assess this case and none of the details have been medically confirmed.Cardiovascular disease is common in this age group, preexisting disease and/or risk factors could well be a more plausible explanation of the events.Patient history of angina suggests that the most likely contributory factor for the event is due to progression of existing underlying cardiovascular disease.In light of no further information becoming available from the user's family, a definitive conclusion regarding device involvement in the incident is not possible.Risk analysis of the incident concludes that the risk of a similar event occurring is improbable.Therefore, at this time we conclude this event to be classified, as a result of an underlying patient condition.Should further information be forth coming, we reserve the right to reassess this conclusion.As such we consider this case to be closed.Further investigations planned: post market surveillance will continue to be monitored for further occurrences of incidents of a similar nature in this or similar devices.

Event Description

Patient's daughter reported: patient purchased an aerosure medic device approximately 2 weeks ago, on the second day of use the patient developed a tickle in his throat, on subsequent days the patient experienced tiredness.On the sixth day the patient was admitted to hospital with a heart attack.Subsequent to the initial heart attack, the patient's liver and kidneys shut down.The patient remains in hospital with a poor prognosis.Further information in regard to patient status is unknown.

• Brand Name: AEROSURE MEDIC
• Type of Device: ELECTRONIC RESPIRATORY MUSCLE TRAINER
• Manufacturer (Section D): ACTEGY LTD; reflex; cain road; bracknell, berkshire RG12 1HL; UK RG12 1HL
• Manufacturer (Section G): PROVIDENCE ENTERPRISE LIMITED; 5-4 neihuan road; shanxia village; pinghu, shenzhen ; CH
• Manufacturer Contact: lawrence brookfield ; reflex; cain road; bracknell, berkshire RG12 -1HL ; UK RG12 1HL
• MDR Report Key: 7556497
• MDR Text Key: 109636411
• Report Number: 3010078417-2018-00007
• Device Sequence Number: 1
• Product Code: BWF
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K140772
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Patient
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: AEROSURE MEDIC
• Device Catalogue Number: 1307
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Device Age: 1 YR
• Event Location: Home
• Date Manufacturer Received: 04/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 76 YR