MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-10 for NONE LTE700DCM manufactured by Neurovision Medical Products Inc..
[69581309]
Patient Sequence No: 1, Text Type: N, H10
[69581310]
Physician was performing a thyroidectomy and the electrodes on the et monitoring kit would not work. This occurred at the beginning of the case after induction. No harm noted to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6394573 |
| MDR Report Key | 6394573 |
| Date Received | 2017-03-10 |
| Date of Report | 2017-03-06 |
| Date of Event | 2017-01-26 |
| Report Date | 2017-02-10 |
| Date Reported to FDA | 2017-02-10 |
| Date Reported to Mfgr | 2017-02-10 |
| Date Added to Maude | 2017-03-10 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NONE |
| Generic Name | ELECTRODE, NEEDLE, DIAGNOSTIC ELECTROMYOGRAPH |
| Product Code | IKN |
| Date Received | 2017-03-10 |
| Model Number | NONE |
| Catalog Number | LTE700DCM |
| Lot Number | 010417D |
| ID Number | ZL138-E |
| Device Expiration Date | 2019-09-01 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEUROVISION MEDICAL PRODUCTS INC. |
| Manufacturer Address | 353 SAN JON RD. VENTURA CA 93001 US 93001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-10 |