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 2018-01-24 for NEOBLUE COZY LED PHOTOTHERAPY SYSTEM 001354 manufactured by Natus Medical Incorporated.
[98414048]
A replacement led board was delivered to the complainant on 1/9/2018. On 1/11/2018, natus technical service contacted the complainant to follow up on the status of the device. No response has been received.
Patient Sequence No: 1, Text Type: N, H10
[98414049]
Natus medical received a report that a neoblue cozy device had multiple leds burnt out and the manufacturer specified intensity couldn't be reached when the potentiometer was turned up to maximum. The complainant was using an ohmeda bili-blanket meter ii to measure intensity with a calibration due date of (b)(6) 2018. When asked for the intensity measurement that was taken, the complainant stated that the median intensity value measured below 35 uw/cm^2/nm. A device timer reading of 3793. 4 hours was provided. There was no report of death, serious injury, delay in treatment, or patient involvement. The neoblue cozy service manual states that the light intensity specification is greater than or equal to 30 uw/cm^2/nm as measured by a neoblue radiometer. Per the conversion chart in the neoblue cozy service manual, a 30 uw/cm^2/nm measurement taken using a neoblue radiometer corresponds to a 28 uw/cm^2/nm measurement taken using an ohmeda bili-blanket meter ii. Therefore, the conversion chart indicates the intensity specification is greater than or equal to 28 uw/cm^2/nm using an ohmeda bili-blanket meter ii. The complainant reported that the intensity was below specification and the measurement taken was less than 35 uw/cm^2/nm. However, because the conversion chart indicates the specification is greater than or equal to 28 uw/cm^2/nm, it was not possible to determine if the intensity was actually below the specification or if the user was applying the incorrect specification.
Patient Sequence No: 1, Text Type: D, B5
[115226451]
No response was received from the customer to follow-up communications by natus technical service. It could not be determined whether the replacement led panel resolved the issue. Probable cause was assigned as a failure of the led panel.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3018859-2018-00057 |
| MDR Report Key | 7217186 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-01-24 |
| Date of Report | 2017-12-27 |
| Date Mfgr Received | 2017-12-27 |
| Device Manufacturer Date | 2010-01-13 |
| Date Added to Maude | 2018-01-24 |
| 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 | 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 COZY LED PHOTOTHERAPY SYSTEM |
| Generic Name | NEOBLUE COZY |
| Product Code | LBI |
| Date Received | 2018-01-24 |
| Model Number | 001354 |
| Device Availability | * |
| Device Age | DA |
| 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 | 2018-01-24 |