MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-08-22 for BIO-LOGIC ABAER 580-ABBOX1002 manufactured by Natus Medical Incorporated.
[118404773]
It was reported to natus that an abaer device was generating results that were deemed inconsistent and questionable to the user. The user had screened the patient three times. Initial screening was performed 36 hours after birth, followed by an additional screening 24 hours later; both reportedly performed as inpatient and using the same abaer device. The initial screening result was refer for both ears. The second screening result was pass for the left ear and refer for the right ear. The third screening was performed two weeks later during an outpatient appointment using a different abaer device, and the result was pass for both ears. Both of the abaer devices were recently calibrated on (b)(6) 2016. The patient had already been scheduled for a diagnostic appointment two weeks later irrespective of the screening results because their sibling had cochlear implants for enlarged vestibular aqueduct. At the diagnostic appointment, the patient was diagnosed with bilateral severe hearing loss. The screening results were received and analyzed by subject matter experts in natus engineering. No determination could be concluded for the discrepancy in results. Natus technical service sent the complainant a white paper for abaer which provides sensitivity information, specificity information, and the test rules used by the system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2018-00146 |
| MDR Report Key | 7806050 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-08-22 |
| Date of Report | 2016-05-16 |
| Date Mfgr Received | 2016-05-16 |
| Date Added to Maude | 2018-08-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JAMES FITZGERALD |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal | 98108 |
| Manufacturer Phone | 2062685173 |
| Manufacturer G1 | NATUS MEDICAL INCORPORATED |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98108 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIO-LOGIC ABAER |
| Generic Name | ABAER |
| Product Code | GWJ |
| Date Received | 2018-08-22 |
| Model Number | 580-ABBOX1002 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICAL INCORPORATED |
| Manufacturer Address | 5900 FIRST AVENUE SOUTH SEATTLE WA 98108 US 98108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-22 |