MAUDE Adverse Event Report: NATUS MEDICAL NEOBLUE PHOTOTHERAPY

Model Number NEOBLUE

Device Problems Component Incompatible (1108); Nonstandard Device (1420)

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

Event Date 10/11/2017

Event Type  malfunction  

Event Description

I am a biomedical engineering technician at (b)(6) hospital in (b)(6).We recently received recall replacement of 2, natus neoblue phototherapy units.The new model light panel is different, and the intensity of the blue spectrum of the light cannot be measured with natus' bill meter.I was told by natus tech support that there had been an investigation into the issue and it was found that this new model cannot be measured with our current meters.The clinical staff take this measurement before use and document the value in the patient record.Currently, they have no way of knowing if the device is working properly and documenting the value in the patient record , which causes them to violate hospital protocol.We were not warned by natus when we received these devices, and i have not received a return call from the sales rep about getting a meter that can measure the output.I don't even know if a radiometer is on the market that can measure the blue spectrum on this device.This basically renders this device inoperable in the clinical environment, and if the clinical staff are not alerted, it will lead to false data being entered into the patient record, and potentially causing misdiagnosis.

• Brand Name: NEOBLUE PHOTOTHERAPY
• Type of Device: NEOBLUE PHOTOTHERAPY
• Manufacturer (Section D): NATUS MEDICAL
• MDR Report Key: 6958019
• MDR Text Key: 89929209
• Report Number: MW5072808
• Device Sequence Number: 1
• Product Code: LBI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEOBLUE
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other