MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-02-11 for NATUS ALGO 2E 040517 manufactured by Natus Medical Inc.
[20942689]
The nurses have complained many times about the difficulty of using the natus hearing screener; especially, the jelly tab sensors (electrodes) provided by natus. The staff has tried to use the standard electrodes (3m red dot). They saw an immediate improvement in performance. The staff stated that the screen is completed in half the time. They had less difficulties with keeping the electrodes attached or obtaining a good signal. Natus sensors are designed for an infant's sensitive skin, but do not seem to perform adequately. Natus electrodes are not optimal for obtaining quality results quickly. The device lists the equipment as well as the natus jelly tab sensors.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1604770 |
| MDR Report Key | 1604770 |
| Date Received | 2010-02-11 |
| Date of Report | 2010-02-11 |
| Date of Event | 2010-02-10 |
| Report Date | 2010-02-11 |
| Date Reported to FDA | 2010-02-11 |
| Date Added to Maude | 2010-02-18 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NATUS |
| Generic Name | ELECTRODES, INFANT HEARING SCREENER |
| Product Code | EWO |
| Date Received | 2010-02-11 |
| Model Number | ALGO 2E |
| Catalog Number | 040517 |
| Lot Number | N0521209-1 |
| ID Number | * |
| Operator | NURSE |
| Device Age | 4 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICAL INC |
| Manufacturer Address | ONE BIOLOGIC PLAZA MUNDELEIN, IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-02-11 |