MAUDE Adverse Event Report: MECTA CORPORATION MECTA; ECTDEVICE

Device Problem Device Operational Issue (2914)

Patient Problem Depression (2361)

Event Date 09/09/2011

Event Type  malfunction  

Manufacturer Narrative

Not possible to followup on the malfunction report.However, this event could occur for the following reasons: mecta ect devices test the impedance of the patient electrode contact with the skin in order to avoid causing a skin burn if the impedance is too high.High patient impedance may be caused by any of the following: faulty electrode wires, use of non-conductive electrode gel, use of disposable electrodes (especially if past their use by data), tarnished electrodes, poor connection due to hair, some medications, poor hydration, condition of some elderly patients, poor skin preparation.

Event Description

Unable to deliver ect treatment due to high patient impedance.

• Brand Name: MECTA
• Type of Device: ECTDEVICE
• Manufacturer (Section D): MECTA CORPORATION; 19799 sw 95th ave. suite b; tualatin OR 97062
• Manufacturer (Section G): MECTA CORPORATION; 19799 sw 95th avenue suite b; tualatin OR 97062
• Manufacturer Contact: robin nicol ; 19799 sw 95th avenue suite b; tualatin, OR 97062 ; 5036126780
• MDR Report Key: 7294044
• MDR Text Key: 101014738
• Report Number: 3020533-2018-00009
• Device Sequence Number: 1
• Product Code: GXC
• Combination Product (y/n): N
• PMA/PMN Number: K965070
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/29/2011
• Initial Date FDA Received: 02/23/2018
• 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: N
• Patient Sequence Number: 1