MAUDE Adverse Event Report: COSTA MESA MFG DC HT70 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	HT70M-JP-NA
Medical Device Problem Codes	Defective Alarm (1014); No Flow (2991); Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a position change, the peak airway pressure of this ht70 ventilator was lower than usual, no alarm sound was generated and the unit stopped ventilating.The patient was removed from the ventilator and placed on an alternate ventilator without injury.
Additional Manufacturer Narrative
Section a patient information and section e initial reporter cannot be provided due to japanese privacy regulations.Section e.Japan medtronic personnel reported event to manufacturer on behalf of the customer.H3: medtronic has not received the suspect device/component from the customer for evaluation nor has the device been evaluated by the medtronic service engineer.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.
Additional Manufacturer Narrative
Section h6 evaluation codes were updated based on additional information method code (annex b): remove b17 and add b13 result code (annex c): remove c20 and add c19 conclusion code (annex d): remove d15 and add d14 h3 additional information: medtronic conducted an investigation based upon all information received.It was reported that during a position change, the peak airway pressure of this ht70 ventilator was lower than usual and no alarm sound was generated and the unit stopped ventilating.The ventilator was not made available to medtronic for evaluation.The third party service provider (b)(4) evaluated the unit but could not reproduce the reported issue.The investigation found the device to function normally as expected.The unit had tested in specifications/performed as intended.Section 6.3.1 of ht70 operator manual outlines that "the low pressure alarm determines the minimum pressure that must be attained in the breathing circuit during mandatory breaths.It should be set as close to the patient¿s normal peak pressure as possible.The low pressure alarm limit does not apply to any breaths in the spont mode or to spontaneous breaths in simv mode".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: HT70 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COSTA MESA MFG DC; 1620 sunflower ave; costa mesa CA 92626
• Manufacturer (Section G): COSTA MESA MFG DC; 1620 sunflower ave; costa mesa CA 92626
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21379782
• Report Number: 2023050-2025-00006
• Device Sequence Number: 21008834
• Product Code: CBK
• UDI-Device Identifier: 10884521542075
• UDI-Public: 10884521542075
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111146
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2025

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: HT70M-JP-NA
• Device Catalogue Number: HT70M-JP-NA
• 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: 01/17/2025
• Supplement Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 04/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2011
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown