MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-12-13 for CYCLOPS CART PK1141 manufactured by Natus Medical Inc. Dba Excle-tech Ltd (xltek).
[130344923]
The unit was not returned to natus therefore a failure investigation could not be performed to identify the root cause. Based on the description of the issue, it appears to be issue related to mechanical force during transport through the hallway. A replacement unit was sent to the customer.
Patient Sequence No: 1, Text Type: N, H10
[130344924]
The wheel fell off caused the cart to fall over in (b)(6) 2017. The customer called in (b)(6) 2018 to request for a replacement part and informed about this event. The camera did not fall during use for patient care, it fell during transport through the hallway. The cart fell over while moving/being transported through the hospital. There was not a bump no injured occured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612330-2018-00024 |
| MDR Report Key | 8161259 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-12-13 |
| Date of Report | 2018-01-19 |
| Date of Event | 2017-04-21 |
| Date Mfgr Received | 2018-01-19 |
| Date Added to Maude | 2018-12-13 |
| 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 | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CYCLOPS CART |
| Generic Name | ELECTROENCEPHALOGRAPH |
| Product Code | GWQ |
| Date Received | 2018-12-13 |
| Model Number | PK1141 |
| 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 | 2018-12-13 |