MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-04-25 for BIS 186-0106 manufactured by Aspect Medical.
[106621718]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[106621719]
According to the reporter, prior to use, a reading or impedance check issue occurred, the device's electrode number 2 had a high reading at sensor check. It was reported that the forehead was cleaned using an alcohol swab. It was indicated that there was patient injury.
Patient Sequence No: 1, Text Type: D, B5
[117306387]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[117306388]
According to the reporter, during use, a reading or impedance check issue occurred, the device's electrode number 2 had a high reading at sensor check. It was reported that the forehead was cleaned using a alcohol swab. It was indicated that there was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936999-2018-00297 |
| MDR Report Key | 7458370 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-04-25 |
| Date of Report | 2018-08-15 |
| Date of Event | 2018-02-05 |
| Date Mfgr Received | 2018-07-26 |
| Date Added to Maude | 2018-04-25 |
| 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 | AVI KLUGER |
| Manufacturer Street | 15 HAMPSHIRE ST. |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 3035306582 |
| Manufacturer G1 | ASPECT MEDICAL |
| Manufacturer Street | 1 UPLAND RD |
| Manufacturer City | NORWOOD MA 02062 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02062 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIS |
| Generic Name | ELECTRODE, CUTANEOUS |
| Product Code | GXY |
| Date Received | 2018-04-25 |
| Returned To Mfg | 2018-07-24 |
| Model Number | 186-0106 |
| Catalog Number | 186-0106 |
| Lot Number | 186-0106 |
| Device Expiration Date | 2015-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASPECT MEDICAL |
| Manufacturer Address | 1 UPLAND RD NORWOOD MA 02062 US 02062 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-04-25 |