MAUDE Adverse Event Report: QUASAR MEDICAL (THAILAND) CO LTD MICROSTREAM ADVANCE; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Model Number	MVIIH
Medical Device Problem Code	Failure to Analyze Signal (1539)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant products: mviih adv neo intubated long term lot#c240417204 mviih adv neo intubated long term lot#c240417204 mviih adv neo intubated long term lot#c240417204 mviih adv neo intubated long term lot#c240417204 mviih adv neo intubated long term lot#c240417204 mviih adv neo intubated long term lot#c240417204 mviih adv neo intubated long term lot#c240417204 mviih adv neo intubated long term lot#c240417204 mviih adv neo intubated long term lot#c240417204.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 prior to use, the unit had no measurement.There was no patient involvement.
Event or Problem Description
According to the reporter, prior to use, the unit had no measurement.There was no patient involvement.
Additional Manufacturer Narrative
Product analysis # (b)(4): one mviih adv neo intubated long term filterline was received with customer stating, ¿no measure¿.Visual inspection showed no visible damage.The filterline was connected to a capnostream 35 (cl-15793) and a cannister of calibration gas where the filterline was recognized and displayed readings as expected when pressing and letting go of the cannister.No fault was found.Filterline was retained after analysis.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 ADVANCE
• Common Device Name: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): QUASAR MEDICAL (THAILAND) CO LTD; 340-1 moo 6 bowin sub-district; chonburi,20 20230 ; TH 20230
• Manufacturer (Section G): QUASAR MEDICAL (THAILAND) CO LTD; 340-1 moo 6 bowin sub-district; chonburi,20 20230 ; TH 20230
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 22534931
• Report Number: 2936999-2025-00389
• Device Sequence Number: 7488062
• Product Code: CCK
• UDI-Device Identifier: 20884521761985
• UDI-Public: (01)20884521761985(11)240422(10)C240417204(20)16
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K181467
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2025

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: MVIIH
• Device Catalogue Number: MVIIH
• Device Lot Number: C240417204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Supplement Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1385-2025
• Patient Sequence Number: 1
• Patient Sex: Unknown