MAUDE Adverse Event Report: MECTA CORPORATION MECTA SPECTRUM 5000Q; ECTDEVICE

Model Number SPECTRUM 5000 Q

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Depression (2361)

Event Date 09/17/2008

Event Type  Death  

Manufacturer Narrative

(b)(4) 2008 mecta notified of patient death.On 9/26/2008 received notice from (b)(4) technical services that an independent expert assessment of the device would be made and that we could have a representative in attendance.On 9/30/2008 received notice of acceptance that our representative, (b)(4), would atten the assessment.On 10/3/2008 received notice that the assessment would take place on 10/15/2008.On 10/3/2008 (b)(4) made arrangements to be at the assessment.On 10/16/2008 (b)(4) emailed and said the assessment gave the device a clean bill of health and said the device would go back into service.On 10/17/2008 (b)(4), director, risk management, quality and patient safety, (b)(4) emailed and said "we do not have any indication that the machine contributed to this tragic event: not from the preliminary verbal feedback from the coroner, and following the assessment of the machine on oct.15, 2008.However, we are not in possession of any documentation, and the coroner's office is reviewing the event." on 3/31/2009 (b)(4), mecta quality manager, contacted the coroner's office.He was advised "that no report was available, nor would one be available for 8 months.Further, mecta would not be able to obtain the coroner's report without authorization from the family of the deceased".Further, we would not be given any information about the family.On 8/14/2009 (b)(4) contacted (b)(4) again.She responded on 8/25/2009 that she would be returning to her office on 8/25 and would get back to us then.On 8/27/2009 (b)(4), president of mecta, emailed (b)(4) asking for a copy of the assessment report.On 8/13, 8/26, 8/27, 9/1/2009 audit by fda, issued a 483 for not filing mdr report for this event on 8/28/2009 (b)(4) sent us a copy of the device assessment report.On 9/3/2009 sent letter to fda regarding the 483 that included extensive documentation of our followup as well as our rationale for not reporting the event.On 10/12/2009 (b)(4) added a note to our file addressing our decision not to report this event to the fda.

Event Description

A patient died in the recovery area shortly after receiving an ect treatment.

• Brand Name: MECTA SPECTRUM 5000Q
• 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: 7294052
• MDR Text Key: 100883277
• Report Number: 3020533-2018-00013
• Device Sequence Number: 1
• Product Code: GXC
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K965070
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SPECTRUM 5000 Q
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/17/2008
• 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
• Patient Outcome(s): Death
• Patient Age: 81 YR