MAUDE Adverse Event Report: JIANGYIN SINBON ELECTRONICS CO LTD INVOS; OXIMETER, TISSUE SATURATION

Model Number	PMAC71RSC
Medical Device Problem Codes	Image Display Error/Artifact (1304); Defective Device (2588); Communication or Transmission Problem (2896); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant product: pmac71rsc, sensor cable re-usable pmac71rsc invos (lot#2023-04-28); pmac71rsc, sensor cable re-usable pmac71rsc invos (lot#2023-04-28); this report is being submitted as part of remediation activities associated with capa # 643143, which is addressing mdr reporting guidance from fdas 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.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, prior to use, the device was showing no sensor and no cable error straight out of the box.The failure was isolated to the device through swapping.There was no patient involvement.

• Brand Name: INVOS
• Common Device Name: OXIMETER, TISSUE SATURATION
• Manufacturer (Section D): JIANGYIN SINBON ELECTRONICS CO LTD; no. 288 middle chengjiang rd.; jiangyin,100 21443 4; CH 214434
• Manufacturer (Section G): JIANGYIN SINBON ELECTRONICS CO LTD; no. 288 middle chengjiang rd.; jiangyin,100 21443 4; CH 214434
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 22061657
• Report Number: 2936999-2025-00304
• Device Sequence Number: 7812084
• Product Code: MUD
• UDI-Device Identifier: 10884521780125
• UDI-Public: 10884521780125
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K182868
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/21/2025

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: PMAC71RSC
• Device Catalogue Number: PMAC71RSC
• Device Lot Number: 2023-04-28
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2023
• Initial Report FDA Received Date: 05/21/2025
• Date Device Manufactured: 04/28/2023
• 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: PLEASE SEE NOTE ON H11
• Patient Sex: Unknown