MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-12-07 for BIS 186-1046 manufactured by Aspect Medical.
[129895063]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[129895064]
Medtronic received a report indicating that the unit began to emit smoke and a flame was observed. The staff unplugged the unit and removed the unit from the room. The unit was not in use on a patient at the time of the event and there was no harm to the patient or hospital staff. The facility has indicated that the unit is not returning to medtronic for evaluation at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936999-2018-00765 |
| MDR Report Key | 8142643 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-12-07 |
| Date of Report | 2018-12-07 |
| Date of Event | 2018-11-26 |
| Date Mfgr Received | 2018-11-27 |
| Date Added to Maude | 2018-12-07 |
| 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 | BIOMEDICAL ENGINEER |
| 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 | 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 |
| Product Code | OLW |
| Date Received | 2018-12-07 |
| Returned To Mfg | 2019-03-05 |
| Model Number | 186-1046 |
| Catalog Number | 186-1046 |
| Device Expiration Date | 2017-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-12-07 |