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

Model Number	180-03
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, the power plug connector of the cuff controller was broken, unable to insert the power cord.There was no patient involvement.
Additional Manufacturer Narrative
H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the ac connector power jack in the controller appears to be dislodged and loose inside the controller.The controller back panel was removed to better observe the loose connector power jack.Upon opening the back panel, the connector power jack was resting loose inside the controller adjacent to the pcba.Visual inspection of the connector power jacks show terminal 1 is bent.Remnants of solder is noted on the bottom of terminal 2, with a torn layer of surface finish on both terminals 1 and 3.Small solder spots noted under terminal 2 is indicative of insufficient solder.Solder spots are noted on the surface mounting pad of the pcba for terminal 2.It was reported that the power plug connector of the cuff controller was broken, unable to insert the power cord.The reported issue was confirmed.The most likely cause was the dislodged j1 component may be associated with insufficient soldering in conjunction with the inadvertent force used to insert the adapter into the power jack as well as the tension when unplugging the adapter.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it has met all medtronic quality specifications.This report is being submitted as part of remediation activities associated with capa # 643143, which is addressing mdr reporting gu idance from fda's 1995 preamble, which ensures complaints related to corrections and recalls which were previously reported to fda under 21 cfr 806 are now reported as mdrs; this is not a new malfunction/event.H9: z-2651-2023.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: 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: 20339878
• Report Number: 3004593495-2024-00034
• Device Sequence Number: 7931710
• Product Code: BSK
• UDI-Device Identifier: 10884521782495
• UDI-Public: 10884521782495
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K202874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 09/30/2024

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: 08/09/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2023
• Initial Report FDA Received Date: 09/30/2024
• 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: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: SEE H11
• Patient Sequence Number: 1
• Patient Sex: Unknown