MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-01-30 for NEOBLUE 3 LED PHOTOTHERAPY SYSTEM 001103 manufactured by Natus Medical Incorporated.
[98976795]
Natus technical service advised the complainant to replace the constant current pcb, and a replacement constant current pcb was delivered to the complainant on 1/8/2018. Natus technical service followed up with the complainant concerning the status of the device on 1/24/2018 and 1/29/2018. No response was received.
Patient Sequence No: 1, Text Type: N, H10
[98976796]
Natus received a report that the intensity of a neoblue 3 device (installed (b)(6) 2014) was below specifications. While measuring 12" below the center of the device, the complainant reported intensity readings of 30 and 26 uw/cm^2/nm on the high setting and 7 and 12 uw/cm^2/nm on the low setting. A natus neoblue radiometer (calibrated 8/2017) was used to measure intensity. The neoblue 3 service manual states that the light intensity specification is 35? 3. 5 uw/cm^2/nm on the high setting and 15? 2 uw/cm^2/nm on the low setting as measured by a neoblue radiometer. There was no report of death, serious injury, delay in treatment, or environmental/safety concerns.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2018-00079 |
| MDR Report Key | 7229678 |
| Report Source | USER FACILITY |
| Date Received | 2018-01-30 |
| Date of Report | 2018-01-02 |
| Date Mfgr Received | 2017-01-02 |
| Device Manufacturer Date | 2014-03-28 |
| Date Added to Maude | 2018-01-30 |
| 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 | KYLE HORTON |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal | 98108 |
| Manufacturer Phone | 2068343921 |
| 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 3 LED PHOTOTHERAPY SYSTEM |
| Generic Name | NEOBLUE 3 |
| Product Code | LBI |
| Date Received | 2018-01-30 |
| Model Number | 001103 |
| Device Availability | * |
| 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 | 2018-01-30 |