BILI-METER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-10-12 for BILI-METER manufactured by Natus Medical Incorporated.

Event Text Entries

[89814627] Tech support has made several attempts contacting customer to send a device replacement to resolve the issue, with no response. Product return was not requested. Low intensity of neoblue led lights measured with olympic bili-meters is an ongoing investigation. Should customer provide additional information natus will file a supplemental report as needed.
Patient Sequence No: 1, Text Type: N, H10


[89814628] Natus medical received a complaint on (b)(6) 2017 that their neoblue cozy device measured low when measured with the olympic bilimeter. The customer did not mention any patient involvement or death/serious injury, delay in treatment, or environmental/safety concerns.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3018859-2017-00775
MDR Report Key6946864
Report SourceUSER FACILITY
Date Received2017-10-12
Date of Report2017-09-12
Date Mfgr Received2017-09-12
Device Manufacturer Date2013-03-30
Date Added to Maude2017-10-12
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 ContactMARC RIVAS
Manufacturer Street5900 FIRST AVENUE SOUTH
Manufacturer CitySEATTLE WA 98108
Manufacturer CountryUS
Manufacturer Postal98108
Manufacturer Phone2062685142
Manufacturer G1NATUS MEDICAL INCORPORATED
Manufacturer Street5900 FIRST AVENUE SOUTH
Manufacturer CitySEATTLE WA 98108
Manufacturer CountryUS
Manufacturer Postal Code98108
Single Use3
Remedial ActionRL
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBILI-METER
Generic NameBILI-METER
Product CodeJJQ
Date Received2017-10-12
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerNATUS MEDICAL INCORPORATED
Manufacturer Address5900 FIRST AVENUE SOUTH SEATTLE WA 98108 US 98108


Patients

Patient NumberTreatmentOutcomeDate
10 2017-10-12

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