MAUDE Adverse Event Report: ORIDION MEDICAL SOUTHMEDIC; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Model Number	OM-2125-MDT
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This regulatory report is being submitted due to retrospective review through capa 624392.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
According to the reporter, during a procedure, the patient had a procedural sedation and the device was used to measure end tidal co2 and to provide oxygen to the patient.The reading of the etco2 was 10-11mmhg on approximately 15l/min of o2 and was also reading apnoeia when the patient was not apnoeic.The nurse tried turning down the o2 to zero and making sure the position of the mask was exact however, the reading did not get any more accurate and continued reading low.The device was removed and replaced with a capnoline and a hudson mask was placed over the top for additional o2 supplementation.This worked well and the etco2 reading were appropriate.At the end of the procedure the nurse attempted to use the device again and she reported that the reading was better the second time around and the waveform was present however, the etco2 reading was still below normal.There was no patient injury.

• Brand Name: SOUTHMEDIC
• Common Device Name: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): ORIDION MEDICAL; 7 hamarpeh st.; jerusalem 91235 ; IS 91235
• Manufacturer (Section G): ORIDION MEDICAL; 7 hamarpeh st.; jerusalem 91235 ; IS 91235
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20611814
• Report Number: 8044004-2024-00024
• Device Sequence Number: 17978432
• Product Code: CCK
• UDI-Device Identifier: 10620974002274
• UDI-Public: 10620974002274
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K014211
• 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): 11/05/2024

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: OM-2125-MDT
• Device Catalogue Number: OM-2125-MDT
• Device Lot Number: W57889
• 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: 10/04/2022
• Initial Report FDA Received Date: 11/05/2024
• 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
• Patient Sex: Female