MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-01-09 for NEOBLUE 001103 manufactured by Natus Medical Incorporated.
[96821356]
A replacement led panel was sent to customer to resolve issue. The led panel involved in the complaint was disposed by customer. No further investigation possible, if additional information becomes available natus will provide follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[96821357]
Natus medical received a complaint on (b)(6) 2017 that the intensity of their neoblue 3 unit was lower than specifications and could not be adjusted to meet specifications. The customer initially stated that intensity was measured with a natus neoblue radiometer at 28 [? ]w/cm2/nm on high and 11 [? ]w/cm2/nm on low. The customer requested ordering information for a replacement led panel, and tsr provided it. The customer confirmed there was no death/serious injury, delay in treatment, or environmental/safety concerns.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2018-00021 |
| MDR Report Key | 7176969 |
| Report Source | USER FACILITY |
| Date Received | 2018-01-09 |
| Date of Report | 2017-12-12 |
| Date Mfgr Received | 2017-10-23 |
| Device Manufacturer Date | 2009-01-01 |
| Date Added to Maude | 2018-01-09 |
| 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 | NEOBLUE |
| Generic Name | NEOBLUE 3 |
| Product Code | LBI |
| Date Received | 2018-01-09 |
| 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 | 2018-01-09 |