MAUDE Adverse Event Report: ASPECT MEDICAL BIS

Model Number 186-1046

Device Problem Smoking (1585)

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

Event Date 10/01/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, the unit was smoking.There is no allegation of patient involvement.

Manufacturer Narrative

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.

• Brand Name: BIS
• 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 street; mansfield, MA 02048 ; 3035306582
• MDR Report Key: 7039684
• MDR Text Key: 92805406
• Report Number: 2936999-2017-05625
• Device Sequence Number: 1
• Product Code: ORT
• UDI-Device Identifier: 10884521129511
• UDI-Public: 10884521129511
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K072286
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 186-1046
• Device Catalogue Number: 186-1046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1