MAUDE Adverse Event Report: NELLCOR PURITAN BENNETT IRELAND INVOS; OXIMETER, TISSUE SATURATION

Model Number	RSC-1
Medical Device Problem Codes	Device Alarm System (1012); Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use, the device had an abnormal measurement values.The rso2 value did not change from 80%.Two channels were use.There was no patient injury.
Additional Manufacturer Narrative
D10 concomitant product: safb-sm/intl - unknown - assy sensor adlt sm safb-int10 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
D10 concomitant product: rsc-4, rsc-4 grn reusable sencable channel4 x1, sn# (b)(6) additional information: b5, g3, g6 correction: d4 (model #, catalog #, udi), d10, h5, h8 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
It was reported that during use, the device had an abnormal measurement values.The rso2 value did not change from 80%.Two channels were use.There were no audible and visual alarm.There was no patient injury.
Additional Manufacturer Narrative
H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted showed missing silicon on the cord on both ends of the cable closest to the ports and one of the pins within the port were bent.Functionally, the cable showed no functional issues and showed the expected readings.The issue was resolved by bending the pin back into the correct position.It was reported that during use, the device had an abnormal measurement values.The reported issue was confirmed.The most likely cause was traced to a component failure.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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): NELLCOR PURITAN BENNETT IRELAND; micheal collins rd mervue; galway ; EI
• Manufacturer (Section G): NELLCOR PURITAN BENNETT IRELAND; micheal collins rd mervue; galway ; EI
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21342956
• Report Number: 8020893-2025-00026
• Device Sequence Number: 9003838
• Product Code: MUD
• UDI-Device Identifier: 10884521145597
• UDI-Public: 10884521145597
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K082327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/04/2025

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: RSC-1
• Device Catalogue Number: RSC-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2025
• Supplement Date Received by Manufacturer: 02/10/2025; 09/01/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 02/10/2025; 09/04/2025
• 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
• Patient Sex: Unknown