MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-05-23 for ERGOJUST CART N/A manufactured by Natus Medical Inc. Dba Excle-tech Ltd (xltek).
[145939817]
Following natus complaint procedure, natus has requested the device back for investigation and has not received it yet. No findings available at this moment. Replacement provided to the customer.
Patient Sequence No: 1, Text Type: N, H10
[145939818]
Camera pole fell over from the cart.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612330-2019-00003 |
| MDR Report Key | 8636199 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-05-23 |
| Date of Report | 2019-04-23 |
| Date Mfgr Received | 2019-04-24 |
| Date Added to Maude | 2019-05-23 |
| 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 G1 | NATUS MEDICAL INCORPORATED DBA EXCEL-TECH (XLTEK) |
| Manufacturer Street | 2568 BRISTOL CIRCLE |
| Manufacturer City | OAKVILLE, 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 | 2019-05-23 |
| Returned To Mfg | 2019-06-20 |
| Model Number | N/A |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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, L6H 5S1 CA L6H 5S1 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-23 |