BIS 186-1046

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-29 for BIS 186-1046 manufactured by Aspect Medical.

Event Text Entries

[93631385] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10

[93631386] According to the reporter, the unit showed that patient was awake when patient was clearly asleep. There was no patient harm reported.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2936999-2017-05641
• MDR Report Key: 7068974
• Date Received: 2017-11-29
• Date of Report: 2017-11-29
• Date Mfgr Received: 2017-11-09
• Date Added to Maude: 2017-11-29
• 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: SHARON MURPHY
• Manufacturer Street: 15 HAMPSHIRE STREET
• Manufacturer City: MANSFIELD MA 02048
• Manufacturer Country: US
• Manufacturer Postal: 02048
• Manufacturer Phone: 2034925267
• 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: 0

Device Details

• Brand Name: BIS
• Generic Name: ANALYZER, SPECTRUM, ELECTROENCEPHALOGRAM SIGNAL
• Product Code: GWS
• Date Received: 2017-11-29
• Model Number: 186-1046
• Catalog Number: 186-1046
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ASPECT MEDICAL
• Manufacturer Address: 1 UPLAND RD NORWOOD MA 02062 US 02062

Patients

Patient Number	Treatment	Outcome	Date
1	0		2017-11-29