MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-15 for ERGOJUST CART 024779 N/A manufactured by Natus Medical Inc. Dba Excle-tech Ltd (xltek).
[127365750]
Following natus complaint procedure, natus performed the investigation. It was concluded that customer failed to follow the installtion instruction provided with the bracket kit. The bracket kit was installed properly however screw that tightens the bracket was incorrectly inseted and missed the t-nut slot which resulted in a lossening the screws. Natus field service employee sent onsite to install the bracket correctly.
Patient Sequence No: 1, Text Type: N, H10
[127365751]
New ergojust bracket is coming loose and a screw was missing. Natus fields service employee was on site on oct 25th to inspect the bracket installation and observed that 1 screw was missing and other 3 screws were loose.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612330-2018-00017 |
| MDR Report Key | 8074429 |
| Date Received | 2018-11-15 |
| Date of Report | 2018-10-25 |
| Date of Event | 2018-10-02 |
| Date Mfgr Received | 2018-10-25 |
| Date Added to Maude | 2018-11-15 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ERGOJUST CART |
| Generic Name | ELECTROENCEPHALOGRAPH |
| Product Code | GWQ |
| Date Received | 2018-11-15 |
| Model Number | 024779 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 1. Other | 2018-11-15 |