MAUDE Adverse Event Report: ACTEGY LTD REVITIVE IX; CIRCULATION BOOSTER

Model Number IX

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

Patient Problem Electric Shock (2554)

Event Date 10/20/2016

Event Type  Injury  

Manufacturer Narrative

Unfortunately following the death of the customer no further information could be obtained.

Event Description

Please note: following an fda inspection at actegy ltd between (b)(6) 2018 by mr (b)(6) it was identified this incident should have been reported to fda.Therefore, the following incident is being reported retrospectively: the patient notified actegy on the (b)(6) 2016 that he had received an electric shock from the device.Following the fda finding an attempt was made to contact the customer but we were told that sadly he had died (but not as a result of the revitive ix circulation booster).Actegy customers are typically aged 70+ and this occasionally happens.

• Brand Name: REVITIVE IX
• Type of Device: CIRCULATION BOOSTER
• Manufacturer (Section D): ACTEGY LTD; reflex; cain road; bracknell, berkshire RG12 1HL; UK RG12 1HL
• Manufacturer (Section G): MIRAE MEDI & TECH CO., LTD; 22 baekseokgongdan 5-gil; seobuk-gu, cheonan city; chungnan, ; KS
• Manufacturer Contact: lawrence brookfield ; reflex; cain road; bracknell,, berkshire RG12 -1HL ; UK RG12 1HL
• MDR Report Key: 7552167
• MDR Text Key: 109481799
• Report Number: 3010078417-2018-00002
• Device Sequence Number: 1
• Product Code: NUH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143207
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: IX
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Date Manufacturer Received: 10/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention