MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-02-21 for BIS 186-0195-GE manufactured by Jabil Circuit Singapore Pte Ltd.
[181444150]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[181444151]
According to the reporter, during use, the unit had an inaccurate readings. The module was swapped to isolate the failure. It was stated that they were able to proceed with the surgery, with no delay or ill effect.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936999-2020-00152 |
| MDR Report Key | 9738585 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-02-21 |
| Date of Report | 2020-02-21 |
| Date of Event | 2020-02-05 |
| Date Mfgr Received | 2020-02-06 |
| Device Manufacturer Date | 2015-01-22 |
| Date Added to Maude | 2020-02-21 |
| 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 | AVI KLUGER |
| Manufacturer Street | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 3035306582 |
| Manufacturer G1 | JABIL CIRCUIT SINGAPORE PTE LTD |
| 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 | INDEX-GENERATING ELECTROENCEPHALOGRAPH SOFTWARE |
| Product Code | OLW |
| Date Received | 2020-02-21 |
| Model Number | 186-0195-GE |
| Catalog Number | 186-0195-GE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JABIL CIRCUIT SINGAPORE PTE LTD |
| Manufacturer Address | 1 UPLAND RD NORWOOD MA 02062 US 02062 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-21 |