MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-06-23 for EMU40 manufactured by Natus Medical Inc. Dba Excle-tech Ltd (xltek).
[78275984]
Prior to receipt of this complaint, natus had already received similar complaints and proceeded to a corrective action (ca) henceforth abbreviated as ca to address this issue. The ca found that the error in the labeling took place during servicing activities. Retraining was provided to ensure that servicing procedures are properly followed. Stock units were also checked at the time of ca to find and fix defective units, if any. This particular customer received the reported unit prior to the initiation of this ca. The risk assessment regarding this defect found that the risk is considered minor and tolerable.
Patient Sequence No: 1, Text Type: N, H10
[78275985]
This form is being submitted upon learning that one of our customers submitted a medwatch form to fda with regards to mislabeling of emu40ex. The original complaint was received in (b)(6) 2017. No patient harm occurred. The issue was that two colored strips on emu40ex breakout box that indicate where on the breakout box the input should be connected to, depending on whether the input originates from left or right side of the patient, was reversed in their location.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612330-2017-00002 |
| MDR Report Key | 6663085 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-06-23 |
| Date of Report | 2017-01-27 |
| Date of Event | 2017-01-27 |
| Date Mfgr Received | 2017-01-27 |
| Device Manufacturer Date | 2013-02-11 |
| Date Added to Maude | 2017-06-23 |
| 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 Phone | 2875055 |
| 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 | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EMU40 |
| Generic Name | ELECTROENCEPHALOGRAPH |
| Product Code | GWQ |
| Date Received | 2017-06-23 |
| Returned To Mfg | 2017-05-05 |
| Model Number | EMU40 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-06-23 |