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

Model Number	PMAC71RSC
Medical Device Problem Code	Failure to Analyze Signal (1539)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2023
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); pmac71rsc, sensor cable re-usable pmac71rsc invos (lot#: 2023-04-28); h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the cable of the unit was defective.It was reported that the monitor was powered on but not providing oximetry readings.The reported issue was confirmed.The most likely cause was traced to component failure.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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 cable had no rso2 reading.It did not send any signal to the monitor.It was tested via the field test device of the system.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: 22065511
• Report Number: 2936999-2025-00317
• Device Sequence Number: 8308557
• Product Code: MUD
• UDI-Device Identifier: 10884521780125
• UDI-Public: 10884521780125
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2023
• Initial Report FDA Received Date: 05/21/2025
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PLEASE SEE NOTE ON H11.
• Patient Sex: Unknown