MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-10-24 for CLARITY II CST1000 * manufactured by Sonamed Corp.
[19261566]
A baby was having hearing screening completed on sonamed clarity 1 system. The left ear oae (otoacoustic emissions testing) test failed at all frequencies and the user expected abr (auditory brainstem response) failure also, yet the abr on both ears passed. This seemed wrong, so a re-test was done of the abr and both the right and left ears now 'referred' on the clarity 2. Three other babies were tested and passed abr on the clarity 1 and 'referred' on the clarity 2.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 792068 |
| MDR Report Key | 792068 |
| Date Received | 2006-10-24 |
| Date of Report | 2006-10-24 |
| Report Date | 2006-10-24 |
| Date Reported to FDA | 2006-10-24 |
| Date Added to Maude | 2006-12-12 |
| 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 | CLARITY II |
| Generic Name | HEARING SCREENER, INFANT |
| Product Code | EWO |
| Date Received | 2006-10-24 |
| Model Number | CST1000 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 779707 |
| Manufacturer | SONAMED CORP |
| Manufacturer Address | 1250 MAIN ST WALTHAM MA 02451 US |
| Brand Name | CLARITY II |
| Generic Name | HEARING SCREENER, INFANT |
| Product Code | EWO |
| Date Received | 2006-10-24 |
| Model Number | CST1000 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 2 |
| Device Event Key | 779708 |
| Manufacturer | SONAMED CORP |
| Manufacturer Address | 1250 MAIN ST WALTHAM MA 02451 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-10-24 |