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

Model Number 001354

Device Problems Electrical /Electronic Property Problem (1198); Low Readings (2460)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

A replacement led board was delivered to the complainant on 1/9/2018.On 1/11/2018, natus technical service contacted the complainant to follow up on the status of the device.No response has been received.

Event Description

Natus medical received a report that a neoblue cozy device had multiple leds burnt out and the manufacturer specified intensity couldn't be reached when the potentiometer was turned up to maximum.The complainant was using an ohmeda bili-blanket meter ii to measure intensity with a calibration due date of (b)(6) 2018.When asked for the intensity measurement that was taken, the complainant stated that the median intensity value measured below 35 uw/cm^2/nm.A device timer reading of 3793.4 hours was provided.There was no report of death, serious injury, delay in treatment, or patient involvement.The neoblue cozy service manual states that the light intensity specification is greater than or equal to 30 uw/cm^2/nm as measured by a neoblue radiometer.Per the conversion chart in the neoblue cozy service manual, a 30 uw/cm^2/nm measurement taken using a neoblue radiometer corresponds to a 28 uw/cm^2/nm measurement taken using an ohmeda bili-blanket meter ii.Therefore, the conversion chart indicates the intensity specification is greater than or equal to 28 uw/cm^2/nm using an ohmeda bili-blanket meter ii.The complainant reported that the intensity was below specification and the measurement taken was less than 35 uw/cm^2/nm.However, because the conversion chart indicates the specification is greater than or equal to 28 uw/cm^2/nm, it was not possible to determine if the intensity was actually below the specification or if the user was applying the incorrect specification.

Manufacturer Narrative

No response was received from the customer to follow-up communications by natus technical service.It could not be determined whether the replacement led panel resolved the issue.Probable cause was assigned as a failure of the led panel.

• Brand Name: NEOBLUE COZY LED PHOTOTHERAPY SYSTEM
• Type of Device: NEOBLUE COZY
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED; 5900 first avenue south; seattle WA 98108
• Manufacturer (Section G): NATUS MEDICAL INCORPORATED; 5900 first avenue south; seattle WA 98108
• Manufacturer Contact: kyle horton ; 5900 first avenue south; seattle, WA 98108 ; 2068343921
• MDR Report Key: 7217186
• MDR Text Key: 98414048
• Report Number: 3018859-2018-00057
• Device Sequence Number: 1
• Product Code: LBI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K051869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 12/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 001354
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/27/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/13/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other