MAUDE Adverse Event Report: JABIL CIRCUIT SINGAPORE PTE LTD BIS; ELECTRODE, CUTANEOUS

Model Number 186-0106

Device Problem Incorrect Measurement (1383)

Patient Problem Injury (2348)

Event Date 02/01/2020

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's sensor was fake.It was indicated that the parameter was wrong because the patient had a correct clinical hypnosis but the reading did not show the same result.There was no patient injury.

• Brand Name: BIS
• Type of Device: ELECTRODE, CUTANEOUS
• Manufacturer (Section D): JABIL CIRCUIT SINGAPORE PTE LTD; 1 upland rd; norwood MA 02062
• Manufacturer (Section G): JABIL CIRCUIT SINGAPORE PTE LTD; 1 upland rd; norwood MA 02062
• Manufacturer Contact: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 9799584
• MDR Text Key: 182386837
• Report Number: 2936999-2020-00186
• Device Sequence Number: 1
• Product Code: GXY
• UDI-Device Identifier: 20884521134307
• UDI-Public: 20884521134307
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K093183
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 186-0106
• Device Catalogue Number: 186-0106
• Device Lot Number: 218401002191008112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2020
• Initial Date FDA Received: 03/06/2020
• 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