MAUDE Adverse Event Report: ASPECT MEDICAL BIS; ELECTRODE, CUTANEOUS

Model Number 186-0106

Device Problems High Readings (2459); Failure to Advance (2524); Human-Device Interface Problem (2949)

Patient Problems No Consequences Or Impact To Patient (2199); Discomfort (2330)

Event Date 02/05/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, prior to use, a reading or impedance check issue occurred, the device's electrode number 2 had a high reading at sensor check.It was reported that the forehead was cleaned using an alcohol swab.It was indicated that there was patient injury.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during use, a reading or impedance check issue occurred, the device's electrode number 2 had a high reading at sensor check.It was reported that the forehead was cleaned using a alcohol swab.It was indicated that there was no patient injury.

• Brand Name: BIS
• Type of Device: ELECTRODE, CUTANEOUS
• Manufacturer (Section D): ASPECT MEDICAL; 1 upland rd; norwood MA 02062
• Manufacturer (Section G): ASPECT MEDICAL; 1 upland rd; norwood MA 02062
• Manufacturer Contact: avi kluger ; 15 hampshire st.; mansfield, MA 02048 ; 3035306582
• MDR Report Key: 7458370
• MDR Text Key: 106621718
• Report Number: 2936999-2018-00297
• Device Sequence Number: 1
• Product Code: GXY
• UDI-Device Identifier: 90884521657508
• UDI-Public: 90884521657508
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K093183
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Model Number: 186-0106
• Device Catalogue Number: 186-0106
• Device Lot Number: 186-0106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR