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 2018-08-09 for NEOBLUE COZY LED PHOTOTHERAPY SYSTEM 001354 manufactured by Natus Medical Incorporated.
[116712348]
Natus technical service requested that the complainant fill out a questionnaire regarding the issue and any patient involvement. Natus technical service also asked if a solution had been found to the issue and appropriate results had been obtained by the ekg equipment. The complainant reported that the patient had been taken off of ekg monitoring after the event, and that there have been no similar issues reported since the event. The neoblue cozy and ekg equipment continue to be used by the user facility. The complainant believed the issue to be a one-off incident. Appendix b "electromagnetic specifications" of the neoblue cozy service manual 051915 rev. H states that the customer or user should assure that the neoblue cozy is used in the electromagnetic environment specified in table b. 1. Appendix b, table b. 1 states that the neoblue cozy led phototherapy system uses rf energy only for its internal function. Therefore, its rf emissions are very low and are not likely to cause any interference in nearby electronic equipment.
Patient Sequence No: 1, Text Type: N, H10
[116712349]
It was reported to natus that a neoblue cozy unit was generating excessive artifacts in ekg equipment while ekg monitoring. The complainant tried multiple configurations of the ekg equipment and the neoblue cozy to limit the artifact but was unsuccessful. It was reported that the artifact only occurred in the presence of a neoblue cozy and not in the presence of an overhead neoblue unit. There was no report of death, serious injury, or environmental/safety concerns.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2018-00140 |
| MDR Report Key | 7769051 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-08-09 |
| Date of Report | 2018-07-10 |
| Date Mfgr Received | 2018-07-10 |
| Date Added to Maude | 2018-08-09 |
| 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 |
| 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 COZY LED PHOTOTHERAPY SYSTEM |
| Generic Name | NEOBLUE COZY |
| Product Code | LBI |
| Date Received | 2018-08-09 |
| Model Number | 001354 |
| 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. Other | 2018-08-09 |