MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-08-17 for NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM 006254 manufactured by Natus Medical Incorporated.
[117858369]
Natus technical service made multiple attempts to request answers to the following questions. No response was received and the cause of the issue could not be determined. What date did the incident occur? Was it ever determined what the rash was? How long did the rash last? Has the baby required any additional treatment for the rash? What is the doctor's name and contact information?
Patient Sequence No: 1, Text Type: N, H10
[117858410]
It was reported to natus that a patient developed a rash and redness in the skin after being treated with a neoblue blanket. The rash was "moderately bad" with increased redness and bumps. The patient had spots along their spine and under the top of their diaper on their back side. The redness and rash was treated by allowing the affected area to be open to air. The patient had been treated for 24 hours with the neoblue blanket unit. The average intensity of the unit measured with a neoblue radiometer at 5 different points on the mattress was 40. 8 uw/cm^2/nm, which is within specifications. The light pad was cool to the touch. The mattress had been covered by a new and clean disposable mattress cover prior to treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2018-00139 |
| MDR Report Key | 7794581 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-08-17 |
| Date of Report | 2016-07-28 |
| Date Mfgr Received | 2016-07-28 |
| Date Added to Maude | 2018-08-17 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JAMES FITZGERALD |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal | 98108 |
| Manufacturer Phone | 2062685173 |
| 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 BLANKET LED PHOTOTHERAPY SYSTEM |
| Generic Name | NEOBLUE BLANKET |
| Product Code | LBI |
| Date Received | 2018-08-17 |
| Model Number | 006254 |
| 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 | 1. Required No Informationntervention | 2018-08-17 |