MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-11-28 for PHOTIC STIM manufactured by Natus Medical Inc. Dba Excle-tech Ltd (xltek).
[128582491]
Following natus complaint procedure, the photic system was investigated. The cable found broken at the end of lower arm. Normal wear and tear failure due to the mechanical movement. Replacement device provided to the customer.
Patient Sequence No: 1, Text Type: N, H10
[128582492]
Spark was observed on photic device. Power cord was found damaged upon inspection of the device, incident has no effect on patient/user safety.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612330-2018-00022 |
| MDR Report Key | 8110329 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-11-28 |
| Date of Report | 2015-08-27 |
| Date of Event | 2015-08-27 |
| Date Mfgr Received | 2015-08-27 |
| Date Added to Maude | 2018-11-28 |
| 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 | PHOTIC STIM |
| Generic Name | PHOTIC STIMULATOR |
| Product Code | GWE |
| Date Received | 2018-11-28 |
| 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 | 2018-11-28 |