MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-23 for NEOBLUE BLANKET 006254 manufactured by Natus Medical Inc..
[100784049]
Patient Sequence No: 1, Text Type: N, H10
[100784050]
During phototherapy treatment utilizing an led phototherapy light source and detachable phototherapy blanket with light coupler, the clinician noted smoke emitting from the attachment point between the light coupler hose and led light source connection point. The clinician removed the phototherapy system from the patient and turned the unit off. Inspection of the led light source noted charring and burning of the led output lens. Charring and burning was also noted on the end of the phototherapy blanket light coupler. Inspection of additional units noted the same charring on an additional led light source. Both devices removed from service and sent to biomedical engineering for reporting and company analysis. No patient harm. Manufacturer response for phototherapy system, neoblue blanket (per site reporter). Manufacturer setting up exchange process to exchange units after hospital release.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7291608 |
| MDR Report Key | 7291608 |
| Date Received | 2018-02-23 |
| Date of Report | 2018-02-20 |
| Date of Event | 2018-01-17 |
| Report Date | 2018-02-20 |
| Date Reported to FDA | 2018-02-20 |
| Date Reported to Mfgr | 2018-02-20 |
| Date Added to Maude | 2018-02-23 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEOBLUE BLANKET |
| Generic Name | UNIT, NEONATAL, PHOTOTHERAPY |
| Product Code | LBI |
| Date Received | 2018-02-23 |
| Model Number | NEOBLUE BLANKET |
| Catalog Number | 006254 |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICAL INC. |
| Manufacturer Address | 5900 FIRST AVE SOUTH SEATTLE WA 98108 US 98108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-23 |