MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-04-13 for NATUS ALGO3 * manufactured by Natus Medical.
[1205359]
While the nurse was preparing to use the hearing screener on an infant she received a painful shock from a frayed cable attached to one of the ear pieces. Biomed removed the equipment from use and ordered a replacement transducer cable. After contacting the manufacturer, the entire system was returned for evaluation. The manufacturer was unable to duplicate this problem. System has been returned to use. ====================== manufacturer response for infant hearing screener, natus======================manufacturer was very concerned and requested we return the entire system for evaluation. A loaner was sent immediately and our system was returned to them for evaluation. The cause for the shock could not be determined however.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1366455 |
| MDR Report Key | 1366455 |
| Date Received | 2009-04-13 |
| Date of Report | 2009-04-13 |
| Date of Event | 2009-02-09 |
| Report Date | 2009-04-13 |
| Date Reported to FDA | 2009-04-13 |
| Date Added to Maude | 2009-04-22 |
| 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 | HEARING SCREENER, NEWBORN |
| Product Code | EWO |
| Date Received | 2009-04-13 |
| Returned To Mfg | 2009-02-12 |
| Model Number | ALGO3 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Availability | R |
| Device Age | 3 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICAL |
| Manufacturer Address | 1501 INDUSTRIAL ROAD SAN CARLOS CA 94070 US 94070 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-04-13 |