MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-04-05 for AMBU NEUROLINE CUP ELECTRODES UNKNOWN manufactured by Ambu A/s.
[141079739]
There were no catalog number, lot number or complaint sample available for further investigations. The complaint was received through a fda maude report, which only identify that an ambu eeg electrodes were involved in the described event, without any specifications on the product. Neither did the maude report include name or contact information of the initial reporter, so no follow-up questions could be asked. We were therefore unable to investigate the failure due to limited and incomplete information provided. However, ambu cup eeg electrodes are intended only for recording biopotential signals, and do not act as a stimulator, meaning that the electrodes are passive and can not generate any current and thereby not cause electrical burns when used according to ifu.
Patient Sequence No: 1, Text Type: N, H10
[141079740]
Patient waw wearing the cup-electrodes over a proximal period of 24h, and experienced red burns, when removing the electrodes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610691-2019-00005 |
| MDR Report Key | 8487914 |
| Report Source | OTHER |
| Date Received | 2019-04-05 |
| Date of Report | 2019-04-05 |
| Date of Event | 2019-01-16 |
| Date Facility Aware | 2019-03-08 |
| Report Date | 2019-03-08 |
| Date Reported to Mfgr | 2019-03-08 |
| Date Mfgr Received | 2019-03-08 |
| Date Added to Maude | 2019-04-05 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SANJAY PARIKH |
| Manufacturer Street | 6230 OLD DOBBIN LANE SUITE 250 |
| Manufacturer City | COLUMBIA MD 21045 |
| Manufacturer Country | US |
| Manufacturer Postal | 21045 |
| Manufacturer Phone | 4107686464 |
| Manufacturer G1 | AMBU INC |
| Manufacturer Street | 6230 OLD DOBBIN LANE SUITE 250 |
| Manufacturer City | COLUMBIA MD 21045 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 21045 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMBU NEUROLINE CUP ELECTRODES |
| Generic Name | AMBU EEG LEADS |
| Product Code | GXY |
| Date Received | 2019-04-05 |
| Catalog Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMBU A/S |
| Manufacturer Address | BALTORPBAKKEN 13 BALLERUP, DK-2750 DA DK-2750 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-05 |