MAUDE Adverse Event Report: PLEXUS MANUFACTURING SDN. BHD. PURITAN BENNETT; CUFF, TRACHEAL TUBE, INFLATABLE

Model Number	180-03
Medical Device Problem Codes	Smoking (1585); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
According to the reporter, during installation and starting the new cuff controller, smoke was coming out of the device for about 20 seconds and switched off the unit.There were no indicators of an error.There was no patient involvement and no injury to operators.
Additional Manufacturer Narrative
H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the battery experienced a thermal event.There were signs of leakage on the sides and on the battery positive terminal.There were also signs of where the plastic sleeve of the battery had melted and indentations on the battery.Further investigation revealed damage to both the pcb and a blown fuse.There was evidence of burning and melting plastic to various surface mounted components, including integrated circuits, connector interfaces and the pcb itself.It was reported that during installation; after inserting the battery correctly, the unit blew air briefly after 20 seconds and started smoking very badly without putting the unit on.The unit was not connected to the mains.The battery also appears to have exploded.The battery was quickly removed and the device stopped smoking.There were no indicators of an error.The reported issue was confirmed.The most likely cause was determined to be a component issue.Internal process improvements have been initiated to mitigate this issue.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.
Additional Manufacturer Narrative
Correction: b5, 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 battery experienced a thermal event.There were signs of leakage on the sides and on the battery positive terminal.There were also signs of where the plastic sleeve of the battery had melted and indentations on the battery.Further investigation revealed damage to both the pcb and a blown fuse.There was evidence of burning and melting plastic to various surface mounted components, including integrated circuits, connector interfaces and the pcb itself.It was reported that during installation, after inserting the battery correctly, the unit blew air briefly after 20 seconds and started smoking without putting the unit on.The unit was not connected to the mains.The battery also appeared to have exploded.The battery was quickly removed and the device stopped smoking.There were no indicators of an error.The reported issue was confirmed.The reported issue was confirmed.The most likely cause was determined to be manufacturing related.Internal process improvements have been initiated to mitigate this issue.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
According to the reporter, during installation, after inserting the battery correctly, the unit blew air briefly after 20 seconds and started smoking without putting the unit on.The unit was not connected to the mains.The battery also appeared to have exploded.The battery was quickly removed and the device stopped smoking.There were no indicators of an error.There was no patient involvement and no injury to operators.

• Brand Name: PURITAN BENNETT
• Common Device Name: CUFF, TRACHEAL TUBE, INFLATABLE
• Manufacturer (Section D): PLEXUS MANUFACTURING SDN. BHD.; bayan lepas fiz, phase ii; bayan lepas,pin 11900 ; MY 11900
• Manufacturer (Section G): PLEXUS MANUFACTURING SDN. BHD.; bayan lepas fiz, phase ii; bayan lepas,pin 11900 ; MY 11900
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20446329
• Report Number: 3004593495-2024-00041
• Device Sequence Number: 15476542
• Product Code: BSK
• UDI-Device Identifier: 10884521782495
• UDI-Public: 10884521782495
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K202874
• 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,Followup
• Report Date (Section B): 03/22/2025

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: 180-03
• Device Catalogue Number: 180-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2024
• Supplement Date Received by Manufacturer: 12/12/2024; 02/20/2025
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 01/11/2025; 03/22/2025
• 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
• Patient Sex: Unknown