MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2018-08-17 for NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM 006254R manufactured by Natus Medical Incorporated.
[117588427]
Return of the device was requested by natus technical service. The device was not returned. Natus medical initiated a field safety corrective action for the neoblue blanket systems in (b)(6) 2015 as a result of investigations conducted by natus medical. These investigations showed that this failure occurs after extended exposure to the intense light source within the box, at which time the pad no longer provides the therapeutic treatment for which it is intended. Natus is in the process on confirming a neoblue blanket configuration which will not be susceptible to the degradation described above.
Patient Sequence No: 1, Text Type: N, H10
[117588428]
It was reported to natus that the fiber optic bundle of a neoblue blanket light pad had melted. Irradiance of the light pad was reported to have decreased over the treatment period of 33. 5 hours from 31. 2 uw/cm^2/nm to 7-15 uw/cm^2/nm, which is lower than specifications. At the end of this treatment period, the users noticed a burning smell and the light pad was hot to the touch. The light pad was removed from the patient and swapped with a different light pad. It was confirmed by the complainant that there was no death, serious injury, delay in treatment, or environmental/safety concerns.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2018-00144 |
| MDR Report Key | 7794087 |
| Report Source | FOREIGN |
| Date Received | 2018-08-17 |
| Date of Report | 2018-07-19 |
| Date of Event | 2018-07-06 |
| Date Mfgr Received | 2018-07-19 |
| Date Added to Maude | 2018-08-17 |
| 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 | JAMES FITZGERALD |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal | 98108 |
| Manufacturer Phone | 2062685173 |
| 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 |
| Removal Correction Number | Z-1412-2015 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM |
| Generic Name | NEOBLUE BLANKET |
| Product Code | LBI |
| Date Received | 2018-08-17 |
| Model Number | 006254R |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-08-17 |