MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-04-08 for CYCLOPS CART 10426 manufactured by Natus Medical Inc. Dba Excel-tech Ltd (xltek).
[141244582]
Customer confirmed that the component is broken due to the device stuck with the storage room door frame while being moved in to storage room. A replacement component is sent to the customer. This is an isolated incident. And there was no safety hazard to the patient or user.
Patient Sequence No: 1, Text Type: N, H10
[141244583]
Cart was being moved into a storage room but height of door frame was too low and video extensions had struck the door frame causing the sleeve to break. Nobody was injured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612330-2019-00002 |
| MDR Report Key | 8492924 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-04-08 |
| Date of Report | 2019-03-25 |
| Date of Event | 2019-03-25 |
| Date Mfgr Received | 2019-03-26 |
| Date Added to Maude | 2019-04-08 |
| 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 | 2019-04-08 |
| Model Number | 10426 |
| 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 EXCEL-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 | 2019-04-08 |