MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-03-21 for NEOBLUE 3 LED PHOTOTHERAPY SYSTEM 001103 manufactured by Natus Medical Incorporated.
[103178356]
Natus technical service shipped the complainant a replacement constant current pcb (potentiometers are attached to the constant current pcb). The complainant confirmed that the issue was resolved by installing the replacement constant current pcb.
Patient Sequence No: 1, Text Type: N, H10
[103178357]
Natus received a report that an intensity adjustment potentiometer on a neoblue 3 device was broken. There was no report that intensity was out of specifications. There was no report of death, serious injury, delay in treatment, or environmental/safety concerns.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 3018859-2018-00110 |
MDR Report Key | 7360457 |
Report Source | USER FACILITY |
Date Received | 2018-03-21 |
Date of Report | 2018-02-21 |
Date Mfgr Received | 2018-02-21 |
Device Manufacturer Date | 2014-06-25 |
Date Added to Maude | 2018-03-21 |
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 | KYLE HORTON |
Manufacturer Street | 5900 FIRST AVENUE SOUTH |
Manufacturer City | SEATTLE WA 98108 |
Manufacturer Country | US |
Manufacturer Postal | 98108 |
Manufacturer Phone | 2068343921 |
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 | NEOBLUE 3 LED PHOTOTHERAPY SYSTEM |
Generic Name | NEOBLUE 3 |
Product Code | LBI |
Date Received | 2018-03-21 |
Model Number | 001103 |
Device Availability | * |
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 | 2018-03-21 |