MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-24 for 1902 manufactured by Cambridge Electronic Design Ltd.
[180611879]
Patient having sleep study with eeg monitoring. The leads were attached as routine. The patient developed partial thickness burn under two of the leads. The burns were conservatively managed. The sleep lab contacted the vendor. The vendor and lab troubleshooted the eeg. The lab discovered the leads were not in the correct configuration. The leads were initially configured by the technical representative of the vendor approximately 18 months prior. The leads were reconfigured to correct positions in the device. Manufacturer response for eeg, (brand not provided) (per site reporter). As above, vendor aware and helped troubleshoot.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9744556 |
| MDR Report Key | 9744556 |
| Date Received | 2020-02-24 |
| Date of Report | 2020-02-17 |
| Date of Event | 2020-02-07 |
| Report Date | 2020-02-17 |
| Date Reported to FDA | 2020-02-17 |
| Date Reported to Mfgr | 2020-02-24 |
| Date Added to Maude | 2020-02-24 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | FULL-MONTAGE STANDARD ELECTROENCEPHALOGRAPH |
| Product Code | GWQ |
| Date Received | 2020-02-24 |
| Model Number | 1902 |
| Device Availability | Y |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAMBRIDGE ELECTRONIC DESIGN LTD |
| Manufacturer Address | 139 CAMBRIDGE RD CAMBRIDGE CB24 6AZ ENGLAND, UK US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-24 |