MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-02-23 for MECTA manufactured by Mecta Corporation.
[101014738]
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.
Patient Sequence No: 1, Text Type: N, H10
[101014739]
Unable to deliver ect treatment due to high patient impedance.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3020533-2018-00009 |
| MDR Report Key | 7294044 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-02-23 |
| Date of Report | 2018-01-12 |
| Date of Event | 2011-09-09 |
| Date Mfgr Received | 2011-12-29 |
| 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 | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MECTA |
| Generic Name | ECTDEVICE |
| Product Code | GXC |
| Date Received | 2018-02-23 |
| 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 | 2018-02-23 |