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

Model Number	UNSPECIFIED INVOS PRODUCT
Medical Device Problem Codes	Failure to Analyze Signal (1539); Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant product: pmac71rsc - sensor cable re-usable pmac71rsc invos - (lot#: 2018-04-12).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 the unit had no rso2 reading when attempted to use, the sensors were connected in order according to the flashing cables.The right side had a good connection but had a struggle with the left side.It was tried disconnecting numerous times, restating the console and two new sensor probes, used an abrasive wipe to rough up the forehead, but the same outcome.Then, ended p connecting other device where, readings were on the lower side 50 and right side was 60.Upon, testing the reported unit on a staff member after procedure, a reading was possible on left side but quite low.There was no patient injury.
Additional Manufacturer Narrative
Additional information: h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Functional testing found that the unit was unable to get readings on the left side of the preamp.It was reported that the unit had no rso2 reading when attempted to use.The unit was connected to other devices, the readings on the lower side was 50 and the right side was 60.When the unit was tested on a staff member after the procedure, a reading was possible on the left side, but it was quite low.The reported issues were 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.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: UNSPECIFIED INVOS PRODUCT
• 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: 20901477
• Report Number: 8020893-2024-00412
• Device Sequence Number: 14703840
• Product Code: MUD
• UDI-Device Identifier: 10884521211179
• UDI-Public: 10884521211179
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K091224
• 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,Followup
• Report Date (Section B): 03/10/2025

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: UNSPECIFIED INVOS PRODUCT
• Device Catalogue Number: UNSPECIFIED INVOS PRODUCT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2024
• Supplement Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 03/10/2025
• 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