MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-10-30 for ERGOJUST CART IP-HD-EC-VIDEO-EXT N/A manufactured by Natus Medical Inc. Dba Excle-tech Ltd (xltek).
[125618276]
This is a known issue which has been previously investigated and resulted in a fca. The customer has been informed about the field corrective action. The retrofit kit has been provided to customer in august to install on the cart to prevent any such failure. The customer did not installed the kit on the cart. The upgraded version of replacement ergo just cart has been shipped to the customer.
Patient Sequence No: 1, Text Type: N, H10
[125618277]
Ergojust video extension broke where it mounts to the base of the cart. Pictures that the customer sent, shows it broke at the welds. There was no patient or user injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612330-2018-00016 |
| MDR Report Key | 8019648 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-10-30 |
| Date of Report | 2018-10-19 |
| Date of Event | 2018-10-08 |
| Date Mfgr Received | 2018-10-19 |
| Date Added to Maude | 2018-10-30 |
| 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 | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ERGOJUST CART |
| Generic Name | ELECTROENCEPHALOGRAPH |
| Product Code | GWQ |
| Date Received | 2018-10-30 |
| Model Number | IP-HD-EC-VIDEO-EXT |
| 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 | 2018-10-30 |