MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-09-29 for EZSTIM DUAL STIMULATOR/LOCATOR ES400 103278400 manufactured by I-flow, Llc.
[4915923]
It was reported by an i-flow product representative that an anesthesia technician was shocked by a es400 nerve block stimulator during routine inspection in the anesthesia work room. The anesthesia technician reported the following. There was no strong magnetic field in the area of use. He was touching the electrodes that were connected to the connector cables. The electrodes were placed on the right forearm. The stimulator was set on 'double' setting. No medical intervention was given and no injury occurred. *anp: asked not provided*
Patient Sequence No: 1, Text Type: D, B5
[12336389]
Method: the device was received for analysis. At this time the evaluation is anticipated but not yet begun. A review of the device history record (dhr) is in progress. Results: there are no results available as the investigation and evaluation are currently in progress. Conclusions: the investigation is ongoing and has not yet been completed. Once the analysis and investigation are complete a follow-up report will be submitted. Info from this incident will be included in our product complaint and mdr trend reporting system. Additional investigation may arise from ongoing analysis, trend info, or other analysis as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2026095-2014-00187 |
| MDR Report Key | 4137909 |
| Report Source | 05,07 |
| Date Received | 2014-09-29 |
| Date of Report | 2014-09-04 |
| Date of Event | 2014-08-22 |
| Date Mfgr Received | 2014-09-04 |
| Device Manufacturer Date | 2013-10-01 |
| Date Added to Maude | 2014-10-10 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARIA WAGNER |
| Manufacturer Street | 43 DISCOVERY SUITE 100 |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9499232324 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EZSTIM DUAL STIMULATOR/LOCATOR |
| Generic Name | STIMULATOR, NERVE, PERIPHERAL |
| Product Code | KOI |
| Date Received | 2014-09-29 |
| Returned To Mfg | 2014-09-15 |
| Model Number | ES400 |
| Catalog Number | 103278400 |
| Lot Number | ON3030059 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | I-FLOW, LLC |
| Manufacturer Address | IRVINE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-29 |