MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-08-24 for OLYMPIC BILI-METER manufactured by Natus Medical Incorporated.
[83666510]
Natus medical has launched an investigation into this event with the olympic bilimeter. No prior related service records or complaints were found for the last two years for this device. The neoblue mini was adjusted within spec using the neoblue radiometer, by the customer and back in service.
Patient Sequence No: 1, Text Type: N, H10
[83666531]
Natus medical received a complaint on (b)(6) 2017 that their bili-meter was reading low measurements with their neoblue 3 mini. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2017-00612 |
| MDR Report Key | 6818819 |
| Report Source | USER FACILITY |
| Date Received | 2017-08-24 |
| Date of Report | 2017-07-25 |
| Date Mfgr Received | 2017-07-03 |
| Device Manufacturer Date | 2013-08-29 |
| Date Added to Maude | 2017-08-24 |
| 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 | MARC RIVAS |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal | 98108 |
| Manufacturer Phone | 2062685142 |
| Manufacturer G1 | NATUS MEDICAL INCORPORATED |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98108 |
| Single Use | 3 |
| 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 | 2017-08-24 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICAL INCORPORATED |
| Manufacturer Address | 5900 FIRST AVENUE SOUTH SEATTLE WA 98108 US 98108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-08-24 |