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.
[96959953]
Replacement part was sent to customer to resolve the issue. Natus received the affected board back found no issue with the board. Factory service and qa personnel performed the observation and evaluation for led board and found: all switches were working fine. No lights were flicking when the intensity switch was on either low or high setting. Both blue and yellow were all illuminated. When measured the intensity of the device, we obtained 15 [? ]w/cm2/nm for low setting and 35 [? ]w/cm2/nm for high setting. No fault was found. No further investigation possible.
Patient Sequence No: 1, Text Type: N, H10
[96959954]
The customer reported to natus on (b)(6) 2017 that their neoblue 3, installed on (b)(6) 2011 had leds flickering, and measured low. 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 | 3018859-2018-00013 |
| MDR Report Key | 7179314 |
| Report Source | USER FACILITY |
| Date Received | 2018-01-10 |
| Date of Report | 2017-12-11 |
| Date Mfgr Received | 2017-12-11 |
| Device Manufacturer Date | 2011-12-28 |
| 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 | 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 | 2018-01-10 |
| 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 | 1. Other | 2018-01-10 |