MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED NEOBLUE COZY LED PHOTOTHERAPY SYSTEM

Model Number	001354
Medical Device Problem Code	Electromagnetic Compatibility Problem (2927)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Natus technical service requested that the complainant fill out a questionnaire regarding the issue and any patient involvement.Natus technical service also asked if a solution had been found to the issue and appropriate results had been obtained by the ekg equipment.The complainant reported that the patient had been taken off of ekg monitoring after the event, and that there have been no similar issues reported since the event.The neoblue cozy and ekg equipment continue to be used by the user facility.The complainant believed the issue to be a one-off incident.Appendix b "electromagnetic specifications" of the neoblue cozy service manual 051915 rev.H states that the customer or user should assure that the neoblue cozy is used in the electromagnetic environment specified in table b.1.Appendix b, table b.1 states that the neoblue cozy led phototherapy system uses rf energy only for its internal function.Therefore, its rf emissions are very low and are not likely to cause any interference in nearby electronic equipment.
Event or Problem Description
It was reported to natus that a neoblue cozy unit was generating excessive artifacts in ekg equipment while ekg monitoring.The complainant tried multiple configurations of the ekg equipment and the neoblue cozy to limit the artifact but was unsuccessful.It was reported that the artifact only occurred in the presence of a neoblue cozy and not in the presence of an overhead neoblue unit.There was no report of death, serious injury, or environmental/safety concerns.

• Brand Name: NEOBLUE COZY LED PHOTOTHERAPY SYSTEM
• Common Device Name: NEOBLUE COZY
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED; 5900 first avenue south; seattle WA 98108
• MDR Report Key: 7769051
• Report Number: 3018859-2018-00140
• Device Sequence Number: 1758120
• Product Code: LBI
• UDI-Device Identifier: 00382830053198
• UDI-Public: 00382830053198
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K051869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 07/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 001354
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2018
• Initial Report FDA Received Date: 08/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other