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

Model Number	CNN/SNN
Medical Device Problem Codes	Contamination /Decontamination Problem (2895); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/15/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, post operatively, the sensor was working and was left for five days.It was reported that when the probe was removed they discovered a very red forehead.The probe was left off and hydromol was applied.The patient was deceased but the sensor was not the cause of death.The sensor was left on for too long.It was explained that the sensors are expensive and this is why the sensors are not changed every 24 hours.The reporter stated the device did not cause or contribute to the patient event.
Additional Manufacturer Narrative
Evaluation summary: samples were received for evaluation.The sensor was visually examined for any anomalies but no anomalies were observed.The fi test-bed device was tested for proper operation and was observed to operate as specified.The sensor was tested for proper and no errors were observed.The dhr was reviewed and there were no non-conformances found.Information has been added to the database and trends will continue to be monitored.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Correction: d3 additional information: g3 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 20023 3; EI 200233
• Manufacturer (Section G): NELLCOR PURITAN BENNETT IRELAND; micheal collins rd mervue; galway 20023 3; EI 200233
• Manufacturer Contact: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 8528345
• Report Number: 2936999-2019-00291
• Device Sequence Number: 2384409
• Product Code: MUD
• UDI-Device Identifier: 20884521106229
• UDI-Public: 20884521106229
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K091224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CNN/SNN
• Device Catalogue Number: CNN/SNN
• Device Lot Number: A190124G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 03/21/2019
• Supplement Date Received by Manufacturer: 06/20/2019; 08/08/2024
• Initial Report FDA Received Date: 04/18/2019
• Supplement Report FDA Received Date: 07/16/2019; 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2019
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 1 MO
• Patient Sex: Female
• Patient Weight: 2 KG