MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-02-23 for MECTA SPECTRUM 5000Q manufactured by Mecta Corporation.
[101019552]
Not possible to followup on the malfunction report. However, this event is not possible for the following reasons: flip cover cannot hold stimulus button active unless clearly broken. The switch does not control the stimulus delivery, it simply signals the software that a delivery is desired. The software generates an error if the electrodes are not on the patient. The error must be manually cleared and the stimulus button released before a new stimulus sequence can be initiated. If the electrodes are connected and then the button is pushed, 3 warning tones are emitted which last about 6 seconds. These tones warn the doctor delivery is about to occur.
Patient Sequence No: 1, Text Type: N, H10
[101019553]
Cover panel on the stimulus switch was holding switch in the active position as the patient was being attached to the device. The patient received a stimulus immediately instead of during a controlled procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3020533-2018-00006 |
| MDR Report Key | 7294046 |
| Report Source | OTHER |
| Date Received | 2018-02-23 |
| Date of Report | 2018-01-12 |
| Date of Event | 2005-08-22 |
| Date Mfgr Received | 2006-08-26 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 |
| 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 5000Q |
| 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 |