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 MINI LED PHOTOTHERAPY SYSTEM 040823 manufactured by Natus Medical Incorporated.
[98976657]
The complainant inquired about ordering information for a replacement led panel and constant current pcb, which natus technical service provided. Natus received a purchase order for a replacement constant current pcb on 1/5/2018, and the part was delivered to the complainant on 1/8/2018.
Patient Sequence No: 1, Text Type: N, H10
[98976658]
Natus received a report that the intensity of a neoblue mini device could not be adjusted to meet specifications. The complainant reported intensity of 2-3 uw/cm^2/nm when the potentiometer was adjusted to its maximum setting. A natus neoblue radiometer (calibration due 10/2018) was used to measure intensity. The neoblue mini service manual states that the light intensity specification is greater than or equal to 30 uw/cm^2/nm 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 | 3018859-2018-00080 |
| MDR Report Key | 7229679 |
| Report Source | USER FACILITY |
| Date Received | 2018-01-30 |
| Date of Report | 2018-01-02 |
| Date Mfgr Received | 2017-01-02 |
| Device Manufacturer Date | 2005-09-19 |
| 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 MINI LED PHOTOTHERAPY SYSTEM |
| Generic Name | NEOBLUE MINI |
| Product Code | LBI |
| Date Received | 2018-01-30 |
| Model Number | 040823 |
| Device Availability | * |
| Device Age | DA |
| 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 |