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.
[97748314]
Investigations found. The potentiometer on the current board that lowers and highers the intensity level was stripped out from customer pushing too hard on it with a rough tool. The customer confirmed the unit was back within specification, when replaced the damaged current pcb board on-site. No further investigation, needed.
Patient Sequence No: 1, Text Type: N, H10
[97748315]
The customer reported to natus on (b)(6) 2017 that their nb unit had a broken potentiometer on constant current pcb. The customer stated that their staff damaged potentiometer on constant current pcb. The potentiometer on the current board that lower and higher the intensity was stripped out from someone pushing too hard on it with a rough tool. The customer confirmed there was no death/serious injury, delay in treatment, or environmental/safety concerns.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2018-00032 |
| MDR Report Key | 7188424 |
| Report Source | USER FACILITY |
| Date Received | 2018-01-12 |
| Date of Report | 2017-12-14 |
| Date Mfgr Received | 2017-12-15 |
| Device Manufacturer Date | 2016-06-30 |
| 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 | 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 |
| Product Code | LBI |
| Date Received | 2018-01-12 |
| 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 | 2018-01-12 |