MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,user facility report with the FDA on 2020-02-19 for BIS 186-0224-AMS manufactured by Mmj Sa De Cv (usd).
[180096671]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[180096672]
According to the reporter, during use, the patient with elevated greater than 2000 ammonia levels was reporting drastically reduced readings, and it was between 42-71 then peaked in the 80s, then went to minimal readings of 5-30. Multiple sensors were used, but the device was showing 0 for an entire shift. It also stated that the unit had an unknown error code. The device did not record more than zero until the patient died several days later. It was stated that there was no indication that death was related to the product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936999-2020-00141 |
| MDR Report Key | 9729830 |
| Report Source | CONSUMER,USER FACILITY |
| Date Received | 2020-02-19 |
| Date of Report | 2020-02-19 |
| Date of Event | 2020-01-22 |
| Date Mfgr Received | 2020-01-22 |
| Date Added to Maude | 2020-02-19 |
| 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 | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 3035306582 |
| Manufacturer G1 | MMJ SA DE CV (USD) |
| Manufacturer Street | AVE HENEQUEN NO 1181 DESARROLL |
| Manufacturer City | CIUDAD JUAREZ 32590 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 32590 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIS |
| Generic Name | INDEX-GENERATING ELECTROENCEPHALOGRAPH SOFTWARE |
| Product Code | OLW |
| Date Received | 2020-02-19 |
| Model Number | 186-0224-AMS |
| Catalog Number | 186-0224-AMS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MMJ SA DE CV (USD) |
| Manufacturer Address | AVE HENEQUEN NO 1181 DESARROLL CIUDAD JUAREZ 32590 MX 32590 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-02-19 |