MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED OLYMPIC BILI-METER

Model Number 500075-T507

Device Problems Low Test Results (2458); Low Readings (2460); Calibration Problem (2890)

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

Event Type  malfunction  

Manufacturer Narrative

Natus medical has launched an investigation into this event and will file a supplemental report once the investigation is complete.

Event Description

Natus medical received a complaint on (b)(6)2017 that their bili-meter was reading low measurements.A request has been made to return the product for evaluation and calibration.No patient injury reported.

Event Description

Olympic bili-meter intensity readings provided by the complainant at the time of the event were 11.7 uw/cm^2/nm on the high setting and 4.6 uw/cm^2/nm on the low setting.The natus neoblue 3 phototherapy unit being measured with the olympic bili-meter was serial (b)(4).

Manufacturer Narrative

The complainant was sent a neoblue radiometer in replacement of their olympic bili-meter.Natus technical service made multiple follow-up attempts to confirm the status of the neoblue 3 unit and received no response from the complainant.The olympic bili-meter radiometer is a legacy product designed to measure the broad-spectrum light output generated by older technology phototherapy products such as the olympic bili-bassinet.The olympic bili-meter was not intended to measure the narrow-spectrum light output generated by the newer led technology products like the neoblue 3.The neoblue radiometer instead was designed specifically for measurement of the led light output spectrum generated by the neoblue products.Prior to an ongoing natus capa, the service instructions for the neoblue 3 referenced the use of the olympic bili-meter radiometer as an alternate to the preferred neoblue radiometer.Due to technological differences, the bili-meter radiometer readings will differ from neoblue radiometer readings when measuring light output intensity from a neoblue led phototherapy system.As a convenience for neoblue 3 users and/or customers which already had the bili-meter, a conversion chart was provided in the neoblue 3 service manual.A root cause investigation, which took place in the natus capa process, confirmed that the target values listed for the bili-meter radiometer intensity readings in the neoblue 3 conversion chart were too high.This discrepancy led users to the incorrect conclusion that the neoblue 3 units were generating low intensity.The investigation concluded that the root cause was in the conversion chart in the neoblue 3 service manual, and that the neoblue led phototherapy system units and olympic bili-meter radiometers were operating within specifications.This conversion chart has since been removed from the service manual.Natus reported mdrs related to this issue because the neoblue 3 product risk analysis report indicated some potential risk of injury if the phototherapy intensity was not within specification.A clinical evaluation for "low-intensity" was conducted simultaneously with the investigation performed by the capa.Phototherapy does not, in and of itself, expose a patient or user to significant hazard.While it is common that treatment is prescribed as "intensive" phototherapy (based on aap guidelines), studies have shown clinical benefits can be derived from irradiance levels well below 10uw/cm2/nm.Even when the light is functioning according to the prescribed phototherapy intensity, there may still be the need for adjunct therapy, regardless of the intensity.This would not be related to "under treatment;" it would be related to the infant's pathology.

• Brand Name: OLYMPIC BILI-METER
• Type of Device: OLYMPIC BILI-METER
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED; 5900 first avenue south; seattle WA 98108
• MDR Report Key: 6762334
• MDR Text Key: 82782986
• Report Number: 3018859-2017-00535
• Device Sequence Number: 0
• Product Code: MQM
• Combination Product (y/n): N
• PMA/PMN Number: K953005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 07/03/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 500075-T507
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/03/2017
• Initial Date FDA Received: 08/02/2017
• Supplement Dates Manufacturer Received: 07/03/2017
• Supplement Dates FDA Received: 03/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NEOBLUE
• Patient Outcome(s): Other