FDA.reportPublic FDA data

MAUDE MDR 6967011

MDR report key
6967011
Report number
3018859-2017-00816
Event key
0
Event type
3
Date received
2017-10-20
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MARC RIVAS
Address
5900 FIRST AVENUE SOUTH SEATTLE WA 98108 US
Phone
206-206-2062
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BILI-METERBILI-METERNATUS MEDICAL INCORPORATEDJJQ500075-T507* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-10-200

Event Narratives#

N

Patient 1

TECH SUPPORT HELP THE CUSTOMER OVER THE PHONE FOLLOWING THE USER'S MAINTENANCE PROCEDURES AND PROCESSES BY TROUBLESHOOTING THE DEVICE BACK TO REQUIRED SPECIFICATION. NATUS TECH SUPPORT HAS ON SEVERAL OCCASIONS CONTACTED THE CUSTOMER TO MAKE SURE THE DEVICE WAS WORKING CORRECTLY. 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. NO FURTHER INVESTIGATION REQUIRED.

D

Patient 1

NATUS MEDICAL RECEIVED A COMPLAINT ON (B)(6) 2017 THAT THEIR NEOBLUE 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.