MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-01-09 for NEOBLUE 001103 manufactured by Natus Medical Incorporated.
[96823536]
Replacement part has been sent to the customer to resolve the issue. Additional information has been requested from customer, for further investigation. No further investigation possible, if additional information becomes available natus will provide follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[96823537]
On (b)(6) 2017, the customer reported to natus about their neoblue 3 led light output intensity measured low using natus nb radiometer. The customer stated that maximum output with the neoblue radiometer read 25-27 [? ]w/cm2/nm when measured with the natus radiometer at 12 inches below the center. The customer was unable to adjust the potentiometer up and down. The last time the nb device measured by biomed was in (b)(6) 2017, and the output was 30. 5 [? ]w/cm2/nm. 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 | 3018859-2018-00022 |
| MDR Report Key | 7177063 |
| Report Source | USER FACILITY |
| Date Received | 2018-01-09 |
| Date of Report | 2017-12-12 |
| Date Mfgr Received | 2017-12-12 |
| Device Manufacturer Date | 2017-07-07 |
| Date Added to Maude | 2018-01-09 |
| 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 | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEOBLUE |
| Generic Name | NEOBLUE 3 |
| Product Code | LBI |
| Date Received | 2018-01-09 |
| Model Number | 001103 |
| 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 | 2018-01-09 |