FDA.reportPublic FDA data

MAUDE MDR 7188469

MDR report key
7188469
Report number
3018859-2018-00033
Event key
0
Event type
3
Date received
2018-01-12
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
ANA SZUCS
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 BLANKETNATUS MEDICAL INCORPORATEDLBI006254N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-01-1201. O

Event Narratives#

N

Patient 1

NATUS MEDICAL INITIATED A FIELD SAFETY CORRECTIVE ACTION FOR THE NEOBLUE BLANKET SYSTEMS IN APRIL 2015 AS A RESULT OF INVESTIGATIONS CONDUCTED BY NATUS MEDICAL. THESE INVESTIGATIONS SHOWED THAT THIS FAILURE OCCURS AFTER EXTENDED EXPOSURE TO THE INTENSE LIGHT SOURCE WITHIN THE BOX, AT WHICH TIME THE PAD NO LONGER PROVIDES THE THERAPEUTIC TREATMENT FOR WHICH IT IS INTENDED. NATUS IS IN THE PROCESS ON CONFIRMING A NEOBLUE BLANKET CONFIGURATION WHICH WILL NOT BE SUSCEPTIBLE TO THE DEGRADATION DESCRIBED ABOVE.

D

Patient 1

NATUS MEDICAL RECEIVED INFORMATION REGARDING EARLY DEGRADATION/DISCOLORATION OF THE NEOBLUE BLANKET SYSTEM FIBER OPTIC PADS. THESE FAILURES INVOLVED DISCOLORATION/DEGRADATION FOLLOWED BY EVENTUAL MELTING OF THE FIBER OPTIC BUNDLE AT THE CONNECTOR THAT IS INSERTED IN THE NEOBLUE BLANKET LIGHT BOX.