MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-12-19 for ERGOJUST CART IP-EC-DT-CART N/A manufactured by Natus Medical Inc. Dba Excle-tech Ltd (xltek).
[131795377]
In compliance with 21cfr part 820. 198-quality system regulation- and natus quality management system, natus determined this is a known issue. There is a field corrective action (fca) in process for fixing all the affected carts. The replacement parts along with the detailed installation instruction has been sent out to all the affected customers.
Patient Sequence No: 1, Text Type: N, H10
[131795378]
Customer have several eeg carts which are loose at the camera post base, where it connects to the cart itself. Tightened to its limit before it is stripped out, but still loose.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612330-2018-00025 |
| MDR Report Key | 8178718 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-12-19 |
| Date of Report | 2018-05-10 |
| Date Mfgr Received | 2018-05-10 |
| Date Added to Maude | 2018-12-19 |
| 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 | ERGOJUST CART |
| Generic Name | ELECTROENCEPHALOGRAPH |
| Product Code | GWQ |
| Date Received | 2018-12-19 |
| Model Number | IP-EC-DT-CART |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-12-19 |