MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-11-01 for EGOJUST CART - ACCESSORY TO EEG MEDICAL DEVICES IP-HD-EC-VIDEO-EXT N/A manufactured by Natus Medical Inc. Dba Excle-tech Ltd (xltek).
[126554356]
In compliance with 21cfr part 820. 198 - quality system regulations and natus quality management system, we initiated the investigation prior to this complaint. The cause of the problem was identified as defiency in the manufacturing process at our supplier which resulted in weld failure. Following 21cfr part 806, natus has determined that field corrective action required. The fca is in progress to fix all the affected carts.
Patient Sequence No: 1, Text Type: N, H10
[126554357]
Natus field service staff was replacing a computer while he observed two defective camera mast on ergojust carts and found out the weld was cracked on one cart. He requested for replacement of those two carts.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612330-2018-00015 |
| MDR Report Key | 8028553 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-11-01 |
| Date of Report | 2018-02-23 |
| Date of Event | 2018-02-21 |
| Date Mfgr Received | 2018-02-23 |
| Date Added to Maude | 2018-11-01 |
| 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 |
| 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 | EGOJUST CART - ACCESSORY TO EEG MEDICAL DEVICES |
| Generic Name | ELECTROENCEPHALOGRAPH |
| Product Code | GWQ |
| Date Received | 2018-11-01 |
| 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 | 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. Required No Informationntervention | 2018-11-01 |