MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER INVOS; OXIMETER, TISSUE SATURATION

Model Number	PMSENS71-A-10
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This regulatory report is being submitted due to retrospective review through capa 624392.D10 concomitant product: pm7100, monitor pm7100 tablet invos (serial# (b)(6)); pmpamp71, preamplifier pmpamp71 invos 7100, (serial# (b)(6)); pmac71rsc, sensor cable re-usable pmac71rsc invos.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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, while cardiopulmonary resuscitation was ongoing, the monitor booted and, meanwhile, applied the sensor to the forehead of the patient.After being able to see the readings on the monitor, the hcp's wondered why the reading was so low (15% rso2).Immediately used another monitor, which showed a reading of 48%, whereas the other monitor still showed 15%.There was no patient harm.

• Brand Name: INVOS
• Common Device Name: OXIMETER, TISSUE SATURATION
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20622316
• Report Number: 1717344-2024-02056
• Device Sequence Number: 12950837
• Product Code: MUD
• UDI-Device Identifier: 10884521780118
• UDI-Public: 10884521780118
• 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): 11/06/2024

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: PMSENS71-A-10
• Device Catalogue Number: PMSENS71-A-10
• Device Lot Number: AD235202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 11/06/2024
• Date Device Manufactured: 12/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PLEASE SEE NOTE ON H11.
• Patient Sex: Unknown
• Patient Weight: 100 KG