MAUDE Adverse Event Report: NELLCOR PURITAN BENNETT MEXICO SA NELLCOR; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Model Number	PEDICAP
Medical Device Problem Code	Device Ingredient or Reagent Problem (2910)
Health Effect - Clinical Codes	Unspecified Tissue Injury (4559); Unintended Extubation (4564)
Date of Event	03/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, intra-operatively, there were two carbon dioxide detectors (co2 detectors) that did not change color after tracheal intubation.The co2 detector was placed at the end of the tube, and no color change was noted from purple to yellow.Another co2 detector was opened and placed again, and still no color change was noted.Multiple adjustments to the depth of the tube were made to see if it would correct the issue.This resulted in the infant being electively extubated despite clinical signs of intubation.It was also reported that the patient had serious injury.
Additional Manufacturer Narrative
Concomitant product: pedicap paed end tidal c02 detect (lot# 231630030).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: NELLCOR
• Common Device Name: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): NELLCOR PURITAN BENNETT MEXICO SA; boulevard insurgentes 19030; tijuana 22225 ; MX 22225
• Manufacturer (Section G): NELLCOR PURITAN BENNETT MEXICO SA; boulevard insurgentes 19030; tijuana 22225 ; MX 22225
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19570557
• Report Number: 1282497-2024-00168
• Device Sequence Number: 20382738
• Product Code: CCK
• UDI-Device Identifier: 20884521083919
• UDI-Public: 20884521083919
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K944400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/19/2024

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 Expiration Date: 07/09/2025
• Device Model Number: PEDICAP
• Device Catalogue Number: PEDICAP
• Device Lot Number: 231630030
• 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: 05/23/2024
• Initial Report FDA Received Date: 06/19/2024
• Date Device Manufactured: 06/12/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown