MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-12-27 for NEOBLUE 006245 manufactured by Natus Medical Incorporated.
[95916126]
Natus medical initiated a field safety corrective action for the neoblue blanket systems in april 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
[95916127]
Natus medical received information regarding early degradation/discoloration of the neoblue blanket system fiber optic pads. These failures involved discoloration/degradation followed by eventual melting of the fiber optic bundle at the connector that is inserted in the neoblue blanket light box.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2017-01061 |
| MDR Report Key | 7148878 |
| Report Source | USER FACILITY |
| Date Received | 2017-12-27 |
| Date of Report | 2017-11-29 |
| Date Mfgr Received | 2017-11-29 |
| Device Manufacturer Date | 2014-09-25 |
| Date Added to Maude | 2017-12-27 |
| 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 | MARC RIVAS |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal | 98108 |
| Manufacturer Phone | 2062685142 |
| 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 | MA |
| Previous Use Code | 3 |
| Removal Correction Number | Z-1412-2015 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEOBLUE |
| Generic Name | NEOBLUE BLANKET |
| Product Code | LBI |
| Date Received | 2017-12-27 |
| Model Number | 006245 |
| Lot Number | N070214-04 |
| 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 | 1. Other | 2017-12-27 |