MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2018-02-23 for MECTA SPECTRUM 5000Q SPECTRUM 5000 Q manufactured by Mecta Corporation.
[100883277]
(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.
Patient Sequence No: 1, Text Type: N, H10
[100883278]
A patient died in the recovery area shortly after receiving an ect treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3020533-2018-00013 |
| MDR Report Key | 7294052 |
| Report Source | FOREIGN |
| Date Received | 2018-02-23 |
| Date of Report | 2018-01-12 |
| Date of Event | 2008-09-17 |
| Date Mfgr Received | 2008-09-17 |
| Date Added to Maude | 2018-02-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. ROBIN NICOL |
| Manufacturer Street | 19799 SW 95TH AVENUE SUITE B |
| Manufacturer City | TUALATIN OR 97062 |
| Manufacturer Country | US |
| Manufacturer Postal | 97062 |
| Manufacturer Phone | 5036126780 |
| Manufacturer G1 | MECTA CORPORATION |
| Manufacturer Street | 19799 SW 95TH AVENUE SUITE B |
| Manufacturer City | TUALATIN OR 97062 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 97062 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MECTA SPECTRUM 5000Q |
| Generic Name | ECTDEVICE |
| Product Code | GXC |
| Date Received | 2018-02-23 |
| Model Number | SPECTRUM 5000 Q |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MECTA CORPORATION |
| Manufacturer Address | 19799 SW 95TH AVE. SUITE B TUALATIN OR 97062 US 97062 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2018-02-23 |