MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-06-11 for EZSTIM MODEL ES300 * manufactured by Life Tech Inc.
[246952]
Co has four of these models (new) and all have failed to function as expected on multiple occasions. The stimulator is supposed to provide a train-of-four mode every ten seconds, indefinitely, when in "auto-repeat" mode. The device intermittently shuts off completely and does not just go out of the "auto-repeat" mode. This action seems independent of whether electro-cautery is in use and this device is supposed to be shielded from these effects. In the operating room this results in the anesthesiologist having to constantly re-start the whole neuromuscular blocking agent monitoring process.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1025298 |
| MDR Report Key | 399358 |
| Date Received | 2002-06-11 |
| Date of Report | 2002-06-11 |
| Date Added to Maude | 2002-06-17 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EZSTIM MODEL ES300 |
| Generic Name | PERIUPHER NERVE STIMULATOR |
| Product Code | KOI |
| Date Received | 2002-06-11 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 388409 |
| Manufacturer | LIFE TECH INC |
| Manufacturer Address | 4235 GREENBRIAR DR STAFFORD TX * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-06-11 |