MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-10-20 for BILI-METER 500075-T507 manufactured by Natus Medical Incorporated.
[90744570]
Tech support help the customer over the phone following the user's maintenance procedures and processes by troubleshooting the device back to required specification. Natus tech support has on several occasions contacted the customer to make sure the device was working correctly. 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. No further investigation required.
Patient Sequence No: 1, Text Type: N, H10
[90744571]
Natus medical received a complaint on (b)(6) 2017 that their neoblue 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 | 3018859-2017-00816 |
| MDR Report Key | 6967011 |
| Report Source | USER FACILITY |
| Date Received | 2017-10-20 |
| Date of Report | 2017-09-21 |
| Date Mfgr Received | 2017-09-21 |
| Device Manufacturer Date | 2017-04-21 |
| Date Added to Maude | 2017-10-20 |
| 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 | BILI-METER |
| Generic Name | BILI-METER |
| Product Code | JJQ |
| Date Received | 2017-10-20 |
| Model Number | 500075-T507 |
| 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 | 2017-10-20 |