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

Model Number	HT70
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: a service engineer (se) inspected the device and found a leak from the pump.The se replaced the pump.The unit passed testing and operated within the manufacturing specifications.Should the replaced component be returned to the manufacturing site, an additional evaluation will be performed and a supplemental report will be submitted.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that while in use on a patient, the ht70 plus ventilator generated a system error alarm message which indicated a loss of ventilation.The patient was placed on an alternate ventilator and there was no harm to the patient as a result of the event.
Event or Problem Description
A result of the event.
Additional Manufacturer Narrative
Additional code added to section h6 evaluation code result.Device evaluation summary: the ht70 pump and manifold assembly was returned to medtronic for failure investigation.A visual inspection of the part was conducted.There were metal shavings evident on the linkage arm of the pump, indicating shredded bearings.The pump was installed in a test ht70 ventilator and ran at the standard test settings.The pump immediately locked up and caused a system error, verifying the complaint.The root cause of this issue was the shredded bearings within the pump.There were no other issues found with the returned component.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HT70 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway
• MDR Report Key: 8511891
• Report Number: 8020893-2019-00083
• Device Sequence Number: 2594313
• Product Code: CBK
• UDI-Device Identifier: 10884521542266
• UDI-Public: 10884521542266
• 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
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2019

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: HT70
• Device Catalogue Number: HT70PM-WW-NA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Initial Date Received by Manufacturer: 03/21/2019
• Supplement Date Received by Manufacturer: 04/29/2019
• Initial Report FDA Received Date: 04/12/2019
• Supplement Report FDA Received Date: 05/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1