MAUDE Adverse Event Report: COVIDIEN HT70 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	HT70PM-WW-NA
Medical Device Problem Codes	Product Quality Problem (1506); No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Issue identified during product analysis.H3 device evaluation summary: medtronic conducted an investigation based upon all information received.While the service personnel(sp) was replacing control board of this ht70 ventilator since the unit did not turn on, the replacement control board was found to be failure out of box.So, sp replaced the control board again.One control board was returned to medtronic for analysis.The control board was attached to test ventilator and powered up.The backup battery alarm was observed after a few minutes of the unit being powered on.The resistors r243 and r244 were found shorted, confirming the control board was faulty.If failure of r243 and r244 occurs while in use on patient, the ventilator response would be a loss of ventilation to the patient.The cause of the reported event was isolated to a faulty resistors r243 and r244 on the control board.The event is included in the trending and monitoring plan.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
During repair for reported event that the ht70 ventilator would not turn on, the replaced new control board failed out of box.The ventilator was not in use on a patient at the time of the reported event.

• Brand Name: HT70 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway,ie
• Manufacturer (Section G): COVIDIEN; micheal collins rd mervue; galway,ie
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 22758918
• Report Number: 8020893-2025-00183
• Device Sequence Number: 21180646
• Product Code: CBK
• UDI-Device Identifier: 10884521544413
• UDI-Public: (01)10884521544413(11)20180924
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K111146
• 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): 08/08/2025

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: HT70PM-WW-NA
• Device Catalogue Number: HT70PM-WW-NA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2025
• Initial Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HT70 CONTROL BOARD MODEL GR105795, SN (B)(6).
• Patient Sex: Unknown