MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-11-28 for EMU40 BREAKOUT BOX 10406-R manufactured by Natus Medical Inc. Dba Excle-tech Ltd (xltek).
[129357802]
In compliance with 21cfr part 820. 198 - quality system regulations and natus quality management system, we initiated the investigation of the event. Issue confirmed. Following 21cfr part 806, natus determined that field corrective action is requried. The fca is in progress to advise users to stop using the device if they observe the burning smell.
Patient Sequence No: 1, Text Type: N, H10
[129357803]
The device had a burning smell and very hot to touch. No pateint/user injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612330-2018-00019 |
| MDR Report Key | 8110444 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-11-28 |
| Date of Report | 2018-06-21 |
| Date of Event | 2018-06-20 |
| Date Mfgr Received | 2018-06-21 |
| Date Added to Maude | 2018-11-28 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR SANJAY MEHTA |
| Manufacturer Street | 2568 BRISTOL CIRCLE |
| Manufacturer City | OAKVILLE, ONTARIO L6H5S1 |
| Manufacturer Country | CA |
| Manufacturer Postal | L6H5S1 |
| Manufacturer G1 | NATUS MEDICAL INCORPORATED DBA EXCEL-TECH (XLTEK) |
| Manufacturer Street | 2568 BRISTOL CIRCLE |
| Manufacturer City | OAKVILLE, ONTARIO L6H5S1 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | L6H5S1 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EMU40 BREAKOUT BOX |
| Generic Name | ELECTROENCEPHALOGRAPH |
| Product Code | GWQ |
| Date Received | 2018-11-28 |
| Model Number | 10406-R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICAL INC. DBA EXCLE-TECH LTD (XLTEK) |
| Manufacturer Address | 2568 BRISTOL CIRCLE OAKVILLE, OAKVILLE ONTARIO L6H 5S1 CA L6H 5S1 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-11-28 |