MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-03-27 for EZ STIM II ES400 manufactured by Life-tech.
[5682739]
An anesthesia nerve stimulator was being utilized to monitor neuromuscular blockade during a surgical procedure. At the conclusion of the procedure, when use of the anesthesia nerve stimulator was discontinued and the electrode sticker was removed a reddened area was identified on the patient's face (at the location of the sticker). The stimulator was taken out of circulation. Of note, staff later discovered that the same nerve stimulator was used on a prior patient who also sustained a similar injury at the location of the electrode.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5041804 |
| MDR Report Key | 4652375 |
| Date Received | 2015-03-27 |
| Date of Report | 2015-03-27 |
| Date of Event | 2015-03-10 |
| Date Added to Maude | 2015-04-03 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EZ STIM II |
| Generic Name | ANESTHESIA NERVE STIMULATOR |
| Product Code | BXN |
| Date Received | 2015-03-27 |
| Model Number | ES400 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIFE-TECH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-03-27 |