FDA.reportPublic FDA data

MAUDE MDR 7177063

MDR report key
7177063
Report number
3018859-2018-00022
Event key
0
Event type
3
Date received
2018-01-09
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
1NEOBLUENEOBLUE 3NATUS MEDICAL INCORPORATEDLBI001103N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-01-090

Event Narratives#

N

Patient 1

REPLACEMENT PART HAS BEEN SENT TO THE CUSTOMER TO RESOLVE THE ISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM CUSTOMER, FOR FURTHER INVESTIGATION. NO FURTHER INVESTIGATION POSSIBLE, IF ADDITIONAL INFORMATION BECOMES AVAILABLE NATUS WILL PROVIDE FOLLOW-UP REPORT.

D

Patient 1

ON (B)(6) 2017, THE CUSTOMER REPORTED TO NATUS ABOUT THEIR NEOBLUE 3 LED LIGHT OUTPUT INTENSITY MEASURED LOW USING NATUS NB RADIOMETER. THE CUSTOMER STATED THAT MAXIMUM OUTPUT WITH THE NEOBLUE RADIOMETER READ 25-27 [?]W/CM2/NM WHEN MEASURED WITH THE NATUS RADIOMETER AT 12 INCHES BELOW THE CENTER. THE CUSTOMER WAS UNABLE TO ADJUST THE POTENTIOMETER UP AND DOWN. THE LAST TIME THE NB DEVICE MEASURED BY BIOMED WAS IN (B)(6) 2017, AND THE OUTPUT WAS 30.5 [?]W/CM2/NM. THE CUSTOMER CONFIRMED THERE WAS DELAY IN TREATMENT, BUT NO DEATH/SERIOUS INJURY OR ENVIRONMENTAL/SAFETY CONCERNS.