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

Model Number	PMAC71RSC
Medical Device Problem Codes	Failure to Analyze Signal (1539); 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	12/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, prior to use, the cable did not work out of the box during installation.The cable was issued on 1.0 software instead of 2.After checking all monitors and pre-amps, it was noted that the lot was part of affected products and did not work out of the box.When the cable was attached, there were no readings and gave an error that stated to replace sensor.The sensor was replaced, the pre amp-was swapped, and the cable was replaced.There was no patient involvement.
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); pmac71rsc, sensor cable re-usable pmac71rsc invos (lot#2023-04-28); pmac71rsc, sensor cable re-usable pmac71rsc invos (lot#2023-04-28); pmac71rsc, sensor cable re-usable pmac71rsc invos (lot#2023-04-28); 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 gu idance 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.
Additional Manufacturer Narrative
Additional information: d9, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.It was reported that the cable did not work out of the box during installation.The cable was issued with 1.0 software instead of 2.When the cable was attached, there were no readings and gave an error that stated to replace sensor.The reported issue was not confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.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: 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: 22062464
• Report Number: 2936999-2025-00316
• Device Sequence Number: 8468908
• Product Code: MUD
• UDI-Device Identifier: 10884521780125
• UDI-Public: 10884521780125
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Followup
• Report Date (Section B): 09/02/2025

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?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2023
• Supplement Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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