MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-01-16 for NEOBLUE 001103 manufactured by Natus Medical Incorporated.
[97869601]
Natus tech support troubleshot the device with the customer over the phone. Tech support instructed the customer to open the enclosure and reseat the connection from the light switch to the current board. Issue resolved onsite. No further investigation required.
Patient Sequence No: 1, Text Type: N, H10
[97869602]
Natus medical received a complaint on (b)(6) 2017, reported that their neoblue 3 led was not producing full bright when turned to the low intensity setting. Issue was found when staff was getting ready to use the device. At high setting, the leds produced full and bright lights; while the device was set at low setting, the leds lights were off. 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 | 3018859-2018-00044 |
| MDR Report Key | 7197898 |
| Report Source | USER FACILITY |
| Date Received | 2018-01-16 |
| Date of Report | 2017-12-19 |
| Date Mfgr Received | 2017-12-19 |
| Device Manufacturer Date | 2014-05-07 |
| Date Added to Maude | 2018-01-16 |
| 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 |
| Product Code | LBI |
| Date Received | 2018-01-16 |
| 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 | 2018-01-16 |