MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-04-04 for NEOBLUE COZY 001354 manufactured by Natus Medical Inc..
[104544345]
The tsr inquired how the measurement was taken, and the customer confirmed the meter sensor was placed over the bubble mattress without the disposable cover. The tsr then suggested to the customer to add the cover and to retake measurements, per manual instructions. The tsr also instructed the customer on how to adjust the intensity using the potentiometers on the unit. On 7 mar 2018, the tsr followed up with the customer on the status of the device and left a message to the customers. On 16 mar 2018, the tsr contacted the customer again to follow up, and the customer confirmed that they were successfully able to adjust the intensity to specifications.
Patient Sequence No: 1, Text Type: N, H10
[104544346]
The customer reported to a natus technical service representative (tsr) that their neoblue cozy unit was reading high (43. 1 microw/cm2/nm) when measured with a natus radiometer. No death, serious injury, or harm to patients/users has been reported. No delays in treatment or environmental concerns have been reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2018-00112 |
| MDR Report Key | 7398451 |
| Report Source | USER FACILITY |
| Date Received | 2018-04-04 |
| Date of Report | 2018-03-06 |
| Date Mfgr Received | 2018-03-06 |
| Date Added to Maude | 2018-04-04 |
| 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 | JIM FITZGERALD |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal | 98108 |
| Manufacturer Phone | 2062685133 |
| Manufacturer G1 | NATUS MEDICAL INC. |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98108 |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEOBLUE COZY |
| Generic Name | NEOBLUE COZY |
| Product Code | LBI |
| Date Received | 2018-04-04 |
| Model Number | 001354 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICAL INC. |
| Manufacturer Address | 5900 FIRST AVENUE SOUTH SEATTLE WA 98108 US 98108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-04-04 |