MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2018-05-31 for AEROSURE MEDIC 1307 manufactured by Actegy Ltd.
[109636411]
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.
Patient Sequence No: 1, Text Type: N, H10
[109636412]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010078417-2018-00007 |
| MDR Report Key | 7556497 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2018-05-31 |
| Date of Report | 2018-05-31 |
| Date of Event | 2016-04-11 |
| Date Mfgr Received | 2016-04-11 |
| Device Manufacturer Date | 2015-08-22 |
| Date Added to Maude | 2018-05-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. LAWRENCE BROOKFIELD |
| Manufacturer Street | REFLEX CAIN ROAD |
| Manufacturer City | BRACKNELL, BERKSHIRE RG121HL |
| Manufacturer Country | UK |
| Manufacturer Postal | RG12 1HL |
| Manufacturer G1 | PROVIDENCE ENTERPRISE LIMITED |
| Manufacturer Street | 5-4 NEIHUAN ROAD SHANXIA VILLAGE |
| Manufacturer City | PINGHU, SHENZHEN |
| Manufacturer Country | CH |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AEROSURE MEDIC |
| Generic Name | ELECTRONIC RESPIRATORY MUSCLE TRAINER |
| Product Code | BWF |
| Date Received | 2018-05-31 |
| Model Number | AEROSURE MEDIC |
| Catalog Number | 1307 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACTEGY LTD |
| Manufacturer Address | REFLEX CAIN ROAD BRACKNELL, BERKSHIRE RG121HL UK RG12 1HL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Required No Informationntervention | 2018-05-31 |