MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-01-12 for NEOBLUE 001103 manufactured by Natus Medical Incorporated.
[97746591]
Natus has launch an investigation into customer reported issue. Natus tech support has recommended using natus radiometer to get intensity measurements for neoblue devices. A supplemental report will be provided once additional information is available.
Patient Sequence No: 1, Text Type: N, H10
[97746592]
The customer reported to natus on (b)(6) 2017 that their hospital staff had a neoblue 3 unit "wasn't working right. " the staff did not specify how the unit failed. The customer reported patient involvement, the patient was transferred to a different phototherapy device. The customer confirmed there was delay in treatment, but no death/serious injury or environmental/safety concerns.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2018-00028 |
| MDR Report Key | 7187479 |
| Report Source | USER FACILITY |
| Date Received | 2018-01-12 |
| Date of Report | 2017-12-13 |
| Date Mfgr Received | 2017-12-13 |
| Device Manufacturer Date | 2017-04-24 |
| Date Added to Maude | 2018-01-12 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEOBLUE |
| Generic Name | NEOBLUE 3 |
| Product Code | LBI |
| Date Received | 2018-01-12 |
| Model Number | 001103 |
| Device Availability | N |
| 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 | 2018-01-12 |