MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-06-09 for EZSTIM DUAL STIMULATOR/LOCATOR ES400 103278400 manufactured by I-flow, Llc,.
[4534912]
Fill volume: na. Flow rate: na. Procedure: na. Cathplace: na. (nurse (b)(6)): a customer reported that 3 people got shocked when using a stimulation, including a pt and 2 nurses. Per hospital policy of the location where problem occurred, pt and procedure related info will not be provided to i-flow. Reference: 22026095-2014-00079/(b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11916128]
Method: the device history record (dhr) review for the suspect lot is currently in progress. The suspect part has been returned and undergoing eval. Results: there are no results available as the investigation and eval is currently being conducted. Conclusions: the device is undergoing an eval but has not yet been completed. At the time of completion, a supplemental report will be submitted. Info from this incident will be included in our product complaint and mdr trend reporting system. Add'l investigation may arise from ongoing analysis, trend info, or other analysis as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2026095-2014-00080 |
| MDR Report Key | 3928570 |
| Report Source | 05 |
| Date Received | 2014-06-09 |
| Date of Report | 2014-05-15 |
| Date of Event | 2014-05-11 |
| Date Mfgr Received | 2014-05-15 |
| Device Manufacturer Date | 2009-09-01 |
| Date Added to Maude | 2014-07-24 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARIA WAGNER |
| Manufacturer Street | 43 DISCOVERY, STE 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 | 2014-06-09 |
| Returned To Mfg | 2014-05-27 |
| Model Number | ES400 |
| Catalog Number | 103278400 |
| Lot Number | 0J2720066 |
| ID Number | NA |
| Device Expiration Date | 2011-09-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | I-FLOW, LLC, |
| Manufacturer Address | IRVINE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-06-09 |