MAUDE Adverse Event Report: COVIDIEN LP BIS; ELECTRODE, CUTANEOUS

Model Number 186-0150-PH

Device Problems Unable to Obtain Readings (1516); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/26/2019

Event Type  malfunction  

Event Description

Bis quatro measures brain activity in adult patients undergoing general anesthesia or sedation.Patient was in the icu and sedated, but these monitoring systems did not function properly, and was not picking up any brain activity of sedated patient.Monitoring sensor was swapped out for a new one, and new sensor worked without issues.

• Brand Name: BIS
• Type of Device: ELECTRODE, CUTANEOUS
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 8669770
• MDR Text Key: 147027927
• Report Number: 8669770
• Device Sequence Number: 1
• Product Code: GXY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/17/2019,05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 186-0150-PH
• Device Catalogue Number: 186-0150-PH
• Device Lot Number: 0308181K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/17/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/05/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1