BIO-LOGIC ABAER 580-ABBOX1002

MAUDE Adverse Event Report

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.

Event Text Entries

[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


MAUDE Entry Details

Report Number3018859-2018-00146
MDR Report Key7806050
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2018-08-22
Date of Report2016-05-16
Date Mfgr Received2016-05-16
Date Added to Maude2018-08-22
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJAMES FITZGERALD
Manufacturer Street5900 FIRST AVENUE SOUTH
Manufacturer CitySEATTLE WA 98108
Manufacturer CountryUS
Manufacturer Postal98108
Manufacturer Phone2062685173
Manufacturer G1NATUS MEDICAL INCORPORATED
Manufacturer Street5900 FIRST AVENUE SOUTH
Manufacturer CitySEATTLE WA 98108
Manufacturer CountryUS
Manufacturer Postal Code98108
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBIO-LOGIC ABAER
Generic NameABAER
Product CodeGWJ
Date Received2018-08-22
Model Number580-ABBOX1002
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerNATUS MEDICAL INCORPORATED
Manufacturer Address5900 FIRST AVENUE SOUTH SEATTLE WA 98108 US 98108


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-08-22

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