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

Model Number	180-03
Medical Device Problem Code	Charging Problem (2892)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, the cuff controller's power cord could not charge the device.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 of the adapter shows the return ac/dc adapter is 12v.Using a multimeter, the voltage was measured showing the adapter was confirmed for 12v.Voltage= 12.154.A known 5v ac/dc adapter was used to verify the correct manufacturer part number and voltage.Voltage= 5.2021.It was reported that the cuff controller's power cord could not charge the device.The reported issue could not be confirmed.The adapter received was for 12v and not 5v, which is deemed the wrong adapter voltage to charge the controller.How and/or why the 12v ac/dc adapter was possibly used and/or returned cannot be determined.The most likely cause could not be determined from the information available.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: 20375714
• Report Number: 3004593495-2024-00040
• Device Sequence Number: 6869005
• Product Code: BSK
• UDI-Device Identifier: 10884521782495
• UDI-Public: 10884521782495
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 10/04/2024

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: 05/28/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2023
• Initial Report FDA Received Date: 10/04/2024
• 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