MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-01-10 for NEOBLUE 001103 manufactured by Natus Medical Incorporated.
[96967280]
Natus tech support walked the customer through and got the device to proper intensity levels. Several attempts have been made to get additional information from customer, without any response. If additional information becomes available natus will provide a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[96967281]
Natus received a complaint on (b)(6)2017 customer reported that their neoblue3 having low intensity. It was measured with ohmeda biliblanket meter ii and the readings were: _at high setting: 26 [? ]w/cm2/nm [lower than spec]_at low setting: 9 [? ]w/cm2/nm [lower than spec]. Several attempts have been made to get additional information from customer. The customer confirmed there was delay in treatment, but no death/serious injury or environmental/safety concerns.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2018-00023 |
| MDR Report Key | 7179966 |
| Report Source | USER FACILITY |
| Date Received | 2018-01-10 |
| Date of Report | 2017-12-12 |
| Date Mfgr Received | 2017-12-12 |
| Device Manufacturer Date | 2015-03-03 |
| Date Added to Maude | 2018-01-10 |
| 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 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 | NEOBLUE |
| Generic Name | NEOBLUE 3 |
| Product Code | LBI |
| Date Received | 2018-01-10 |
| Model Number | 001103 |
| 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 | 2018-01-10 |