MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-10 for ERGO JUST CART- ACCESSORY TO EEG MEDICAL DEVICES IP-EC-DT-CART manufactured by Natus Medical Inc. Dba Excle-tech Ltd (xltek).
[119930593]
In compliance with 21cfr part820. 198 - quality system regulations and natus quality management system, we initiated the investigation of the reported failure. The cause of the problem identified as deficiency in following the instruction. Customer installed a heavier monitor on the cart without adjusting the spring tension as explained in the user manual provided with the cart. Customer has been informed to adjust the tension if non-natus supplied monitor to use.
Patient Sequence No: 1, Text Type: N, H10
[119930594]
Ergojust desktop cart - the adjustable work surface on the cart collapsed and hit someone on the knee causing brief pain on impact. The defective cart was taken out of use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612330-2018-00006 |
| MDR Report Key | 7861895 |
| Date Received | 2018-09-10 |
| Date of Report | 2018-05-08 |
| Date of Event | 2018-05-08 |
| Date Mfgr Received | 2018-05-08 |
| Date Added to Maude | 2018-09-10 |
| 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 | BIOMEDICAL ENGINEER |
| 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 | ERGO JUST CART- ACCESSORY TO EEG MEDICAL DEVICES |
| Generic Name | ELECTROENCEPHALOGRAPH |
| Product Code | GWQ |
| Date Received | 2018-09-10 |
| Returned To Mfg | 2018-06-12 |
| Model Number | IP-EC-DT-CART |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2018-09-10 |