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 2020-02-27 for BIS 186-1046 manufactured by Jabil Circuit Singapore Pte Ltd.
[181387667]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[181387668]
According to the reporter, during service and repair, the device was physically burnt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936999-2020-00170 |
| MDR Report Key | 9762657 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-02-27 |
| Date of Report | 2020-03-18 |
| Date of Event | 2019-12-30 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2011-05-27 |
| Date Added to Maude | 2020-02-27 |
| 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 | 2020-02-27 |
| Returned To Mfg | 2020-01-07 |
| Model Number | 186-1046 |
| Catalog Number | 186-1046 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-02-27 |