MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2017-11-16 for BIS 186-1046 manufactured by Aspect Medical.
[92805406]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[92805407]
According to the reporter, the unit was smoking. There is no allegation of patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[117883335]
Correction: (name, email), (phone). The unit was returned for evaluation and the reported condition was confirmed. The unit was returned in a condition that could not be used to find a root cause for the report. The unit could not be repaired. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[117883336]
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936999-2017-05625 |
| MDR Report Key | 7039684 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2017-11-16 |
| Date of Report | 2018-04-26 |
| Date of Event | 2017-10-01 |
| Date Mfgr Received | 2018-03-20 |
| Device Manufacturer Date | 2012-03-13 |
| Date Added to Maude | 2017-11-16 |
| 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 STREET |
| 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 |
| Product Code | ORT |
| Date Received | 2017-11-16 |
| Returned To Mfg | 2017-10-25 |
| 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 | ASPECT MEDICAL |
| Manufacturer Address | 1 UPLAND RD NORWOOD MA 02062 US 02062 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-16 |