MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-25 for NEOBLUE 006245 manufactured by Natus Medical Incorporated.
[137018001]
Received replacement natus bili blanket/light source from natus. During inspection by biomed engineering, noticed the connector had cracks. Natus was informed of the findings and replacements were sent out. Upon inspection of new batch, identified crack in one of the products. Natus was contacted again and stated that they would stop all shipments until quality control addressed the issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8365765 |
| MDR Report Key | 8365765 |
| Date Received | 2019-02-25 |
| Date of Report | 2019-02-20 |
| Date of Event | 2019-02-15 |
| Report Date | 2019-02-20 |
| Date Reported to FDA | 2019-02-20 |
| Date Reported to Mfgr | 2019-02-25 |
| Date Added to Maude | 2019-02-25 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEOBLUE |
| Generic Name | UNIT, NEONATAL PHOTOTHERAPY |
| Product Code | LBI |
| Date Received | 2019-02-25 |
| Catalog Number | 006245 |
| Lot Number | N102518-04 |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICAL INCORPORATED |
| Manufacturer Address | 5900 FIRST AVE., SOUTH SEATTLE WA 98108 US 98108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-25 |