MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-03-22 for NEOBLUE 3 LED PHOTOTHERAPY SYSTEM 001103 manufactured by Natus Medical Incorporated.
[103298690]
Natus technical service advised the complainant to have the constant current pcb replaced, and provided the complainant with ordering information. Natus technical service made five subsequent attempts to contact the complainant asking about the status of the device, the replacement parts order, details regarding how the initial blue led illumination issue was resolved, and whether there was any patient involvement. No further response was received.
Patient Sequence No: 1, Text Type: N, H10
[103298691]
Natus received an initial report that blue leds were not illuminating when a neoblue 3 device was turned on. Natus technical service advised the complainant to try toggling the intensity switch away from the neutral position and to reseat all cable connections within the unit. The complainant replied that the issue was resolved by following the instructions of natus technical service. However, in the complainant's reply regarding the blue led illumination issue, the complainant reported that intensity on the high setting was measuring higher than specifications while the potentiometers were adjusted to their minimum setting. The complainant reported intensity readings of 37-39 uw/cm^2/nm in some areas using an ohmeda radiometer calibrated in september 2017. Five other phototherapy lights at the user facility were reported to measure within specifications using the ohmeda radiometer in question. The complainant stated that they have never used a natus neoblue radiometer with their neoblue 3 devices. 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 | 3018859-2018-00111 |
| MDR Report Key | 7362417 |
| Report Source | USER FACILITY |
| Date Received | 2018-03-22 |
| Date of Report | 2018-01-17 |
| Date of Event | 2018-01-17 |
| Date Mfgr Received | 2018-01-17 |
| Device Manufacturer Date | 2009-03-15 |
| Date Added to Maude | 2018-03-22 |
| 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 LED PHOTOTHERAPY SYSTEM |
| Product Code | LBI |
| Date Received | 2018-03-22 |
| Model Number | 001103 |
| 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 | 2018-03-22 |