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)
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, the cuff controller's charger was broken before use.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 dc connector power jack in the controller appeared to be dislodged and loose.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 jack shows remnants of solder pads remain attached to bottom of both terminals 1 and 3.Solder spots are noted on the mounting pad of the pcba for terminal 2.The locator pin on the bottom of the connector that is formatted to fit into the through hole on the pcb adjacent to the connector remains intact.Side view of the board adjacent to the j1 component shows the through-hole is open.It¿s possible the hole was milled too close to the edge of the pcb.It was reported that the cuff controller's charger was broken before use.The reported issue was confirmed.The most likely cause was the dislodged j1 component may be associated with possible cold solder in conjunction with the inadvertent force used to insert the adapter into the power jack as well as the tension when unplugging the adapter.A crack or opening on the edge of the pcb adjacent to where the locator pin sets in appears open, it is unsure if this may have contributed to the security of the j1.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: 20339141
• Report Number: 3004593495-2024-00025
• Device Sequence Number: 7945611
• Product Code: BSK
• UDI-Device Identifier: 10884521782495
• UDI-Public: 10884521782495
• Combination Product (Y/N): N
• 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: 06/15/2023
• 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