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

Model Number REVITIVE DX

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

Patient Problem Cardiac Arrest (1762)

Event Date 03/06/2017

Event Type  Injury  

Manufacturer Narrative

Patient outcome: patient treated with stent implant, recovering at home following hospital discharge 5 days after the incident.Patient corrective action: patient has discontinued use of the device.Manufacturer's preliminary analysis: device has been returned for testing and was found to be operating within intended specification.Initial corrective action: device returned for investigation.Further information requested to enable thorough investigation and medical opinion to be sought.

Event Description

Customer purchased the device (b)(6) 2017 for diabetic neuropathy.Used the device for the 2nd time on (b)(6) 2017, settings unknown.On the morning of (b)(6) 2017, jr suffered a heart attack and was hospitalised.Treatment included stent implant, specific location of stent unknown.(b)(6) discharged from hospital (b)(6) 2017.Recovering well at home.

• Brand Name: REVITIVE DX
• Type of Device: CIRCULATION BOOSTER
• Manufacturer (Section D): ACTEGY LTD; reflex; cain road; bracknell, berkshire RG12 1HL; UK RG12 1HL
• Manufacturer (Section G): MIRA MEDI & TECH CO., LTD; 22 baeksuk-dong 5-gil; seobuk-gu; cheonan city, ; KS
• Manufacturer Contact: lawrence brookfield ; reflex; cain road; bracknell, berkshire RG12 -1HL ; UK RG12 1HL
• MDR Report Key: 7556818
• MDR Text Key: 109647065
• Report Number: 3010078417-2018-00008
• Device Sequence Number: 1
• Product Code: NUH
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: REVITIVE DX
• Device Catalogue Number: 2694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2017
• 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?: Yes
• 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): Hospitalization