MAUDE Adverse Event Report: JABIL CIRCUIT SINGAPORE PTE LTD BIS; INDEX-GENERATING ELECTROENCEPHALOGRAPH SOFTWAR

Model Number	PMB4000DOC
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant product: pmb4000acbl, bis adv monitor loc adap cbl pmb4000acbl, serial number: unknown.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that the device was reported to have discharged due to being unplugged.An attempt to insert the power adapter into the docking station for charging revealed that the adapter would not stay securely in place.Upon inspecting the docking station, it was discovered that a minor incident, cable burn, had occurred inside the docking station.To address this, the power cable was secured with cable ties to minimize strain at the point of insertion into the docking station.Additionally, a 12v power supply unit was implemented between the 230v power source and the docking station to act as a safeguard.In the event of a power surge, this unit would be more likely to sustain damage rather than the docking station itself.There was no patient involvement.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the power supply was returned connected to the docking station with zip-ties.The device smelled like burned electronics.The plug that was usually mounted to the printed circuit board assembly (pcba) was in a bag taped to the device.Functionally, the unit was disassembled.Internal inspection found signs of fluid ingress and corrosion on the housing and by the power plug.Power plug was confirmed burned off of the pcba.The ground tab and the bottom of the plug housing remained on the pcba.The back side of the pcba found large solder blobs on the ground tab and power hole.It was reported that a minor incident, cable burn, had occurred inside the docking station.The reported issue was confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: BIS
• Common Device Name: INDEX-GENERATING ELECTROENCEPHALOGRAPH SOFTWAR
• Manufacturer (Section D): JABIL CIRCUIT SINGAPORE PTE LTD; 16 tampines crescent; singapore 52860 4; SN 528604
• Manufacturer (Section G): JABIL CIRCUIT SINGAPORE PTE LTD; 16 tampines crescent; singapore 52860 4; SN 528604
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 22347716
• Report Number: 2936999-2025-00354
• Device Sequence Number: 20960568
• Product Code: OLW
• UDI-Device Identifier: 10884521808300
• UDI-Public: 10884521808300
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2025

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
• Operator of Device: Health Professional
• Device Model Number: PMB4000DOC
• Device Catalogue Number: PMB4000DOC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2025
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE NOTES IN H11
• Patient Sex: Unknown