MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-06-16 for OLYMPIC BILI-METER 500075-T507 manufactured by Natus Medical Inc..
[77837000]
A request has been made to return the product for investigation. Device requested for evaluation
Patient Sequence No: 1, Text Type: N, H10
[77837001]
The customer reported a low measurement on their bilimeter after it had just come back from calibration. The bilimeter seemed low compared to both past readings and the measurements from their ohmeda meter (taking conversions into account). A request has been made to return the product for investigation.
Patient Sequence No: 1, Text Type: D, B5
[115234939]
The meter was requested back for further evaluation. Per the natus calibration report, the unit was found to be with in specifications and was shipped back to the customer. 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3018859-2017-00353 |
| MDR Report Key | 6648341 |
| Report Source | USER FACILITY |
| Date Received | 2017-06-16 |
| Date of Report | 2017-05-19 |
| Date Mfgr Received | 2017-05-19 |
| Device Manufacturer Date | 2010-05-14 |
| Date Added to Maude | 2017-06-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ANA SZUCS |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal | 98108 |
| Manufacturer Phone | 2062685133 |
| Manufacturer G1 | NATUS MEDICAL INC. |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98108 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPIC BILI-METER |
| Generic Name | OLYMPIC BILI-METER |
| Product Code | JJQ |
| Date Received | 2017-06-16 |
| Model Number | 500075-T507 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICAL INC. |
| Manufacturer Address | 5900 FIRST AVENUE SOUTH SEATTLE WA 98108 US 98108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-06-16 |