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

Model Number	HT70PM-WW-NA
Medical Device Problem Codes	No Flow (2991); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2024
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.It was reported that this ht70 ventilator turns off during self-test and it will not turn on.The device was available for evaluation.The service personnel (sp) inspected the ventilator and confirmed the ventilator would not turn on.To solve the issue, sp replaced the main control board.The ventilator passed all calibrations and tests per manufacturer specifications at the time of service.One main control board was returned to medtronic for failure investigation.During visual inspection the c92 capacitor was found to be cracked.No further testing was performed.If a failure of the c92 capacitor occurs while in use on a patient, the ventilator response would be a loss of ventilation to the patient.The cause of the event was isolated to a faulty c92 capacitor on the main control board.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it has met all medtronic quality specifications.The event is included in a 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
It was reported that this ht70 ventilator turns off during self-test and it will not turn on. the ventilator was not in use on a patient at the time of the reported event.
Additional Manufacturer Narrative
Section h6 evaluation code: conclusion code (annex d) removed d02 and add d01 issue identified during product analysis.H3: device evaluation summary:updated due to additional evaluation of returned part medtronic conducted an investigation based upon all information received.It was reported that this ht70 ventilator turns off during self-test and it will not turn on.The device was available for evaluation.The service personnel (sp) inspected the ventilator, confirmed the ventilator shutdown on its own and replaced the main control board.The ventilator passed all calibrations and tests per manufacturer specifications at the time of service.One main control board was returned to medtronic for failure investigation.During inspection the c92 capacitor was found to be crac ked.If a failure of the c92 capacitor occurs while in use on a patient, the ventilator response would be a loss of ventilation to the patient.The cause of the event was isolated to a faulty c92 capacitor on the main control board.There is an existing previous internal investigation regarding this issue.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): COVIDIEN; michael collins rd mervue; galway,ie ; EI
• Manufacturer (Section G): COVIDIEN; michael collins rd mervue; galway,ie ; EI
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19137909
• Report Number: 8020893-2024-00140
• Device Sequence Number: 18484819
• Product Code: CBK
• UDI-Device Identifier: 10884521544413
• UDI-Public: 10884521544413
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2024

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: HT70PM-WW-NA
• Device Catalogue Number: HT70PM-WW-NA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2024
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2019
• 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