MAUDE Adverse Event Report: SANMINA SCI ISRAEL MEDICAL SYSTEMS MICROSTREAM; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Model Number	PM35MN02
Medical Device Problem Codes	Use of Device Problem (1670); Defective Component (2292); Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 during servicing, the device experienced several issues, including a very slow keypad response, co2 assembly output below the required flow and a co2 pump issue.
Additional Manufacturer Narrative
Medtronic conducted an investigation based upon all information received.The device was available for evaluation.Functional testing found that the keypad response was very slow and the co2 assembly output was below required flow.The issue was resolved by replacing the keypad and co2 assembly, completed post, and calibrating the co2 sensor.It was reported that the device experienced several issues, including a very slow keypad response, co2 assembly output below the required flow and a co2 pump issue.The reported issues were confirmed.The most likely cause was traced to a component failure.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: please charge battery prior to use.The device is shipped with a battery that is not fully charged.Before first use, charge the battery until the removable battery.Indicator indicates that it is fully charged.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: MICROSTREAM
• Common Device Name: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): SANMINA SCI ISRAEL MEDICAL SYSTEMS; haroshet st 5; ma alot tarshiha 24952 ; IS 24952
• Manufacturer (Section G): SANMINA SCI ISRAEL MEDICAL SYSTEMS; haroshet st 5; ma alot tarshiha 24952 ; IS 24952
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21129981
• Report Number: 2936999-2025-00010
• Device Sequence Number: 7516651
• Product Code: CCK
• UDI-Device Identifier: 10884521551596
• UDI-Public: 10884521551596
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K150272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2025

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: PM35MN02
• Device Catalogue Number: PM35MN02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2024
• Supplement Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown