MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-12-27 for BILI LITE 58110 manufactured by Natus Medical Incorporated.
[95920282]
Natus medical investigation found the bili lite a 15 yrs. Old product. A replacement part was sent to the customer to resolve the issue. Customer has been out of town for the holidays, and could not confirm the status of the device. No further investigation required.
Patient Sequence No: 1, Text Type: N, H10
[95920283]
The customer (a biomed) reported on (b)(6) 2017 that two bulb positions in the mattress lamp are always dim. The bulbs were swapped to different holders, but the bulbs in those two positions always remained dim regardless of which bulb was placed there. Olympic bili-bassinet is a discontinued product on 8/24/2011. 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 | 3018859-2017-01033 |
| MDR Report Key | 7149409 |
| Report Source | USER FACILITY |
| Date Received | 2017-12-27 |
| Date of Report | 2017-11-29 |
| Date Mfgr Received | 2017-11-29 |
| Device Manufacturer Date | 2003-06-27 |
| Date Added to Maude | 2017-12-27 |
| 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 | BILI LITE |
| Generic Name | BILI LITE |
| Product Code | LBI |
| Date Received | 2017-12-27 |
| Model Number | 58110 |
| 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 | 2017-12-27 |