MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-01-10 for NEOBLUE 006254, 006245 manufactured by Natus Medical Incorporated.
[96966863]
Several attempts have been made to get additional information from customer, without any response. If additional information becomes available natus will provide a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[96966864]
Natus received a complaint on (b)(6) 2017 customer reported that their neoblue blanket intensity unit was too low. The intensity returned within specifications when the suspect light pad was swapped out for another light pad using the same light box. No model number, serial number, lot number provided or last calibration date of the light pad. Customer did not mention patient involvement at time of report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2018-00019 |
| MDR Report Key | 7179598 |
| Report Source | USER FACILITY |
| Date Received | 2018-01-10 |
| Date of Report | 2017-12-12 |
| Date Mfgr Received | 2017-12-12 |
| Device Manufacturer Date | 2017-07-11 |
| Date Added to Maude | 2018-01-10 |
| 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 | ANA SZUCS |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal | 98108 |
| Manufacturer Phone | 2062685133 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEOBLUE |
| Generic Name | NEOBLUE BALNKET |
| Product Code | LBI |
| Date Received | 2018-01-10 |
| Returned To Mfg | 2018-03-30 |
| Model Number | 006254, 006245 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-01-10 |