MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-10-12 for BILI-METER manufactured by Natus Medical Incorporated.
[89814627]
Tech support has made several attempts contacting customer to send a device replacement to resolve the issue, with no response. Product return was not requested. Low intensity of neoblue led lights measured with olympic bili-meters is an ongoing investigation. Should customer provide additional information natus will file a supplemental report as needed.
Patient Sequence No: 1, Text Type: N, H10
[89814628]
Natus medical received a complaint on (b)(6) 2017 that their neoblue cozy device measured low when measured with the olympic bilimeter. The customer did not mention any patient involvement or death/serious injury, delay in treatment, or environmental/safety concerns.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2017-00775 |
| MDR Report Key | 6946864 |
| Report Source | USER FACILITY |
| Date Received | 2017-10-12 |
| Date of Report | 2017-09-12 |
| Date Mfgr Received | 2017-09-12 |
| Device Manufacturer Date | 2013-03-30 |
| Date Added to Maude | 2017-10-12 |
| 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 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BILI-METER |
| Generic Name | BILI-METER |
| Product Code | JJQ |
| Date Received | 2017-10-12 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2017-10-12 |